510(k) Report

FDA applicant

Chay Medical, LLC

Calistoga, CA2 decisions2002–20020 recalls

FDA records 2 decisions for Chay Medical, LLC (Calistoga, CA) in 2002: 2 510(k) clearances. All are in product code CGA (Glucose Oxidase, Glucose). 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 Chay Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Chay Medical, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Chay Medical, 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?

  • CGAGlucose Oxidase, Glucose2decisions

What has FDA decided for it lately?

  • K021781Excelsior 3UL Test Strips, for Use with the Home Diagnostics, Inc. Prestige LX and IQ Blood Glucose SystemsChay Medical, LLC · 2002
  • K013342Excelsior Test Strips, for Use with the Home Diagnostics, Inc.Chay Medical, LLC · 2002

All 2 as Chay Medical, LLC →