510(k) Report

FDA applicant

Clinical Diagnostic Systems, Inc.

Rochester, NY1 decision1995–19951 recall

FDA records 1 decision for Clinical Diagnostic Systems, Inc. (Rochester, NY) in 1995: 1 510(k) clearance. All are in product code JJE (Analyzer, Chemistry (Photometric, Discrete)…). 1 recall is linked to its devices.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Clinical Diagnostic Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Clinical Diagnostic Systems, Inc. since 2007.

Recalls per year

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Clinical Diagnostic Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K946090Kodak Ektacchem 950IRC AnalyzerClinical Diagnostic Systems, Inc. · 19953cite it

What has FDA decided for it lately?

  • K946090Kodak Ektacchem 950IRC AnalyzerClinical Diagnostic Systems, Inc. · 19951 recall

The one decision as Clinical Diagnostic Systems, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K946090VITROS XT Chemistry Products ALKP SlidesAug 5, 2023Class II