510(k) Report

FDA applicant

Ac Biochemical Laboratories, Inc.

Walker, MI3 decisions1982–19830 recalls

FDA records 3 decisions for Ac Biochemical Laboratories, Inc. (Walker, MI) from 1982 to 1983: 3 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and CHH (Enzymatic Esterase--Oxidase, Cholesterol). 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 Ac Biochemical Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ac Biochemical Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ac Biochemical Laboratories, 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?

  • FMFSyringe, Piston1decision
  • CHHEnzymatic Esterase--Oxidase, Cholesterol1decision
  • KNKAcid, Uric, Uricase (Colorimetric)1decision

What has FDA decided for it lately?

  • K823537Glucose ReagentAc Biochemical Laboratories, Inc. · 1983
  • K823500Cholesterol ReagentAc Biochemical Laboratories, Inc. · 1982
  • K822913Uric Acid ReagentAc Biochemical Laboratories, Inc. · 1982

All 3 as Ac Biochemical Laboratories, Inc. →