510(k) Report

510(k) · Cleared

Cleared

Raichem (TM)Serum Iron and Tibc Reagents

K864819510(k) TraditionalCleared Feb 12, 198765-day reviewClass I21 CFR 862.1410

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

Reagents Applications, Inc. · JIY Photometric Method, Iron (Non-Heme)

Cleared on Feb 12, 1987 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Feb 12, 1987
Review
65 days
Class
Class I
Product code
JIY
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2006: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK864819 Raichem (TM)Serum Iron and Tibc ReagentsReagents Applications, Inc. · 1987
  2. Descendant · cites it directly · 1 of its ownK060205 General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK100263 Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV…Seppim S.A.S. · 2011
  4. Descendant · cites it directly · 0 of its ownK981241 IRONAbbott Laboratories · 1998

Most influential descendants

Showing 3 of 3 · See all
  • K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx · 2006 · cites it directly1descendant
  • K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S. · 2011 · 2 generations on0descendants
  • K981241IRONAbbott Laboratories · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K864819Raichem (TM)Serum Iron and Tibc ReagentsReagents Applications, Inc.1987—
+1K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20062
+2K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.2011—
+1K981241IRONAbbott Laboratories1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200610
201110
FIG. 1 — Lineage of K864819, 1987–2011Source: 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 JIY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (3)

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

NumberDeviceApplicantDecidedDescendants
K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20061
K981241IRONAbbott Laboratories19980

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, K060205 (Horiba Abx, 2006) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JIY devices

JIY Photometric Method, Iron (Non-Heme): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIY

FDA has decided no JIY device since 2007.

Median 510(k) review, days · JIY

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

Recalls per year · JIY

1in 2025

2008: 12009: 82012: 12013: 12016: 32023: 22025: 1
2007high 8 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JIY

7in 2025

2012: 152013: 22016: 22017: 12020: 32021: 22022: 32023: 62024: 82025: 7
2007high 15 (2012) · low 0 (2007)2025

MAUDE reports naming product code JIY, 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—10
20090—80
20100—00
20110—00
20120—115
20130—12
20140—00
20150—00
20160—32
20170—01
20180—00
20190—00
20200—03
20210—02
20220—03
20230—26
20240—08
20250—17
20260—0—

More from Reagents Applications, Inc.

63 FDA decisions under this applicant name. See the company

  • K982056Raichem CO2 ReagentReagents Applications, Inc. · 1998
  • K972853Cholesterol Rapid Liquid ReagentReagents Applications, Inc. · 1997
  • K922904Rai-Trol Fructosamine Serum Controls I and IIReagents Applications, Inc. · 1992
  • K915191Rai-Trol Elevated Lipids ControlReagents Applications, Inc. · 1991
  • K913398Raichem (TM) Creatine Kinase-MB ReagentReagents Applications, Inc. · 1991

Recent decisions in JIY

The JIY category page

  • K061793Dimension Vista Iron Flex Reagent Cartridge and CalibratorDade Behring, Inc. · 20061 recall
  • K060264Dimension Iron Flex Reagent Cartridge (Iron-DF85)Dade Behring, Inc. · 20062 recalls
  • K051115Sentinel Iron LiquidSentinel Ch. Srl · 2005
  • K033983Vitalab Iron ReagentClinical Data, Inc. · 2004
  • K030528Atac Iron Reagent, Atac Tibc Column Kit and Iron Calibrator (500 UG/DL)Clinical Data · 2003

https://510kreport.com/device/K864819 · printed Nov 6, 2026

Cite this page

510(k) Report. “K864819: Raichem (TM)Serum Iron and Tibc Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K864819

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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