510(k) Report

FDA applicant

Calbiochem

Mchenry, IL3 decisions1976–19770 recalls

FDA records 3 decisions for Calbiochem (Mchenry, IL) from 1976 to 1977: 3 510(k) clearances. Most are in product codes JPZ (Colorimetric Method, Gamma-Glutamyl…) and DBM (Antimitochondrial Antibody, Indirect…). 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 Calbiochem’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Calbiochem since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Calbiochem”

FDA records each applicant name separately; these may or may not be the same firm.