510(k) Report

510(k) · Cleared

Cleared

Centrifichem Sys 400 Analyzer

K771813510(k) TraditionalCleared Oct 25, 197728-day reviewClass I21 CFR 862.2140

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

Clinical Diagnostics, Inc. · JJG Analyzer, Chemistry, Centrifugal, For Clinical Use

Cleared on Oct 25, 1977 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 25, 1977
Review
28 days
Class
Class I
Product code
JJG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K771813Source: FDA 510(k) database · 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 JJG? 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
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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All JJG devices

JJG Analyzer, Chemistry, Centrifugal, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJG

FDA has decided no JJG device since 2007.

Median 510(k) review, days · JJG

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

Recalls per year · JJG

No recall names JJG since 2007.

Adverse event reports per year · JJG

5in 2025

2008: 12009: 12012: 12015: 12018: 12020: 862021: 122022: 42023: 52024: 42025: 5
2007high 86 (2020) · low 0 (2007)2025

MAUDE reports naming product code JJG, 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—01
20090—01
20100—00
20110—00
20120—01
20130—00
20140—00
20150—01
20160—00
20170—00
20180—01
20190—00
20200—086
20210—012
20220—04
20230—05
20240—04
20250—05
20260—0—

More from Clinical Diagnostics, Inc.

8 FDA decisions under this applicant name. See the company

  • K971653Glucochek Pocketlab II Blood Glucose SystemClinical Diagnostics, Inc. · 1998
  • K951457Glucochek PocketlabClinical Diagnostics, Inc. · 1996
  • K940215GlucochekClinical Diagnostics, Inc. · 1995
  • K854903Gordon Diagnostic System Model IClinical Diagnostics, Inc. · 1986
  • K771118Centria Separation Columns Type aClinical Diagnostics, Inc. · 1977

Recent decisions in JJG

The JJG category page

  • K972409AG Chemistry Analyzer SystemLandmark Scientific, Inc. · 1997
  • K942782Piccolo (TM)Abaxis, Inc. · 19951 recall
  • K934592Epoc 2000 Point-of-Care Analyzer and Epoc 5-Chemistry Reagent RotorAbaxis, Inc. · 19941 recall
  • K920942Olympus AU800 Clinical Chemistry AnalyzerOlympus Corp. · 1992
  • K910222Cobas AlphaRoche Diagnostic Systems, Inc. · 1991

https://510kreport.com/device/K771813 · printed Nov 4, 2026

Cite this page

510(k) Report. “K771813: Centrifichem Sys 400 Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K771813

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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