510(k) Report

FDA applicant

Chdiagnostics, LLC

Rockville, MD1 decision2003–20031 recall

FDA records 1 decision for Chdiagnostics, LLC (Rockville, MD) in 2003: 1 510(k) clearance. All are in product code LFR (Glucose Dehydrogenase, Glucose). 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 Chdiagnostics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Chdiagnostics, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Chdiagnostics, LLC 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?

  • LFRGlucose Dehydrogenase, Glucose1decision

What has FDA decided for it lately?

  • K032076Senova (R) Blood Glucose MonitorChdiagnostics, LLC · 20031 recall

The one decision as Chdiagnostics, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K032076SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use…Mar 14, 2005