510(k) Report

FDA applicant

Jas Diagnostic, Inc.

Miami, FL1 decision2001–20010 recalls

FDA records 1 decision for Jas Diagnostic, Inc. (Miami, FL) in 2001: 1 510(k) clearance. All are in product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen). No 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 Jas Diagnostic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jas Diagnostic, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Jas Diagnostic, 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?

  • CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K011596Urea Nitrogen (Bun) Liquid ReagentJas Diagnostic, Inc. · 20011cites it

What has FDA decided for it lately?

  • K011596Urea Nitrogen (Bun) Liquid ReagentJas Diagnostic, Inc. · 2001

The one decision as Jas Diagnostic, Inc. →