510(k) Report

510(k) · Cleared

Cleared

Raichem Acid Phasphatase Reagent

K831834510(k) TraditionalCleared Aug 26, 198380-day reviewClass II21 CFR 862.1020

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

Reagents Applications, Inc. · CKB Acid Phosphatase, Naphthyl Phosphate

Cleared on Aug 26, 1983 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Aug 26, 1983
Review
80 days
Class
Class II
Product code
CKB
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared19801990200020102020
  1. This deviceK831834 Raichem Acid Phasphatase ReagentReagents Applications, Inc. · 1983
  2. Descendant · cites it directly · 0 of its ownK974695 Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra…Roche Diagnostic Systems, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K974695Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines with…Roche Diagnostic Systems, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K831834Raichem Acid Phasphatase ReagentReagents Applications, Inc.1983—
+1K974695Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines…Roche Diagnostic Systems, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K831834, 1983–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 CKB? 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K974695Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines with…Roche Diagnostic Systems, Inc.19980

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, K974695 (Roche Diagnostic Systems, Inc., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CKB devices

CKB Acid Phosphatase, Naphthyl Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CKB

FDA has decided no CKB device since 2007.

Median 510(k) review, days · CKB

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

Recalls per year · CKB

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · CKB

2in 2021

2011: 22012: 12021: 2
2007high 2 (2011) · low 0 (2007)2025

MAUDE reports naming product code CKB, 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—02
20120—01
20130—10
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—02
20220—00
20230—00
20240—00
20250—00
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 CKB

The CKB category page

  • K053612Dri-Stat Acid Phosphatase ReagentBeckman Coulter, Inc. · 2006
  • K023840Acid Phosphatase Assay for the Advia 1650Bayer Diagnostics Corp. · 2003
  • K991010ACPAbbott Diagnostics Mfg., Inc. · 1999
  • K981743Olympus AU400 Clinical Chemistry AnalyzerOlympus America, Inc. · 19985 recalls
  • K974695Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines with B-Glucuronidase (Bnzgl)Roche Diagnostic Systems, Inc. · 1998

https://510kreport.com/device/K831834 · printed Nov 5, 2026

Cite this page

510(k) Report. “K831834: Raichem Acid Phasphatase Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K831834

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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