510(k) Report

510(k) · Cleared

Cleared

Immochemistry System

K771603510(k) TraditionalCleared Sep 15, 197724-day reviewClass II21 CFR 866.5510

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Beckman Instruments, Inc. · CZP Iga, Antigen, Antiserum, Control

Cleared on Sep 15, 1977 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.

Decided
Sep 15, 1977
Review
24 days
Class
Class II
Product code
CZP
Recalls
None
Predicates
0

19 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 1997: 5 descendants cleared1996: 1 descendant cleared2003: 3 descendants cleared2000: 2 descendants cleared2005: 1 descendant cleared2004: 1 descendant cleared2006: 3 descendants cleared2014: 1 descendant cleared2019: 1 descendant cleared2013: 1 descendant cleared19801990200020102020
  1. This deviceK771603 Immochemistry SystemBeckman Instruments, Inc. · 1977
  2. Descendant · cites it directly · 7 of its ownK963868 Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M…Beckman Instruments, Inc. · 1997 · Recalled
  3. Descendant · cites it directly · 4 of its ownK973932 Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc. · 1997
  4. Descendant · cites it directly · 4 of its ownK964766 Immage Immunochemistry System Alpha-1-Antitrypsin (Aat)Beckman Instruments, Inc. · 1997
  5. Descendant · 2 generations on · 3 of its ownK052819 Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat…Ortho-Clinical Diagnostics, Inc. · 2005
  6. Descendant · 2 generations on · 3 of its ownK993549 Beckman Coulter Immage Immunochemistry System Low Concentration…Beckman Coulter, Inc. · 2000

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

1996: 11997: 52000: 22003: 32004: 12005: 12006: 32013: 12014: 12019: 1
1996high 5 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 19 · See all
  • K963868Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm)Beckman Instruments, Inc. · 1997 · cites it directly7descendants
  • K973932Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc. · 1997 · cites it directly4descendants
  • K964766Immage Immunochemistry System Alpha-1-Antitrypsin (Aat)Beckman Instruments, Inc. · 1997 · cites it directly4descendants
  • K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2005 · 2 generations on3descendants
  • K993549Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc)…Beckman Coulter, Inc. · 2000 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K771603Immochemistry SystemBeckman Instruments, Inc.1977—
+1K963868Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm)Beckman Instruments, Inc.19972
+1K973932Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc.1997—
+1K964766Immage Immunochemistry System Alpha-1-Antitrypsin (Aat)Beckman Instruments, Inc.1997—
+2K052819Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance…Ortho-Clinical Diagnostics, Inc.2005—
+2K993549Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin…Beckman Coulter, Inc.2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199750
200020
200330
200410
200510
200630
201310
201410
201910
FIG. 1 — Lineage of K771603, 1977–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CZP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CZP device

  1. #1 K193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200…score 0.2 · 3 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (19)

See all 19

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K963868Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm)Beckman Instruments, Inc.19977
K973932Beckman Calibrator 2 (CAL2)Beckman Instruments, Inc.19974
K964766Immage Immunochemistry System Alpha-1-Antitrypsin (Aat)Beckman Instruments, Inc.19974
K964842Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) ReagentBeckman Instruments, Inc.19972
K032035Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4)…Beckman Coulter, Inc.20030
K965108Synchron LX Systems Immunoglobulin G/a/M ReagentBeckman Instruments, Inc.19970
K962294Immage Immunochemistry SystemBeckman Instruments, Inc.19960

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K963868 (Beckman Instruments, Inc., 1997) has gone furthest, with 7 descendants of its own.

How does its category compare?

All CZP devices

CZP Iga, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CZP

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CZP

Too few CZP 510(k)s in any year since 2007 to give a median.

Recalls per year · CZP

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CZP

1in 2025

2011: 12015: 12016: 22017: 12021: 12022: 12024: 22025: 1
2007high 2 (2016) · low 0 (2007)2025

MAUDE reports naming product code CZP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—01
20160—02
20170—01
20180—00
20190—00
20201—00
20210—01
20220—11
20230—00
20240—02
20250—01
20260—0—

More from Beckman Instruments, Inc.

281 FDA decisions under this applicant name. See the company

  • K973448Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465, 34469Beckman Instruments, Inc. · 1998
  • K982250Access Free T4 Reagents on the Access Immunoassay AnalyzerBeckman Instruments, Inc. · 19984 recalls
  • K981403Immage Immunochemistry System Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1998
  • K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc. · 19981 recall
  • K980173Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505Beckman Instruments, Inc. · 19981 recall

Recent decisions in CZP

The CZP category page

  • K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHoriba Abx Sas · 2020
  • K060130Immage Systems Low Concentration Immunoglobulin a ReagentBeckman Coulter, Inc. · 2006
  • K040435Roche Diagnostics Tina-Quant Iga Gen.2Roche Diagnostics Corp. · 20041 recall
  • K024038N Latex IgaDade Behring, Inc. · 2003
  • K993927Wako Iga II-HA, Immunoglobulin Calibrator Set, Immunoglobulin StandradWako Chemicals USA, Inc. · 2000

https://510kreport.com/device/K771603 · printed Nov 5, 2026

Cite this page

510(k) Report. “K771603: Immochemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K771603

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026