510(k) Report

FDA applicant

Bioclinical Systems, Inc.

St.Louis, MO13 decisions1985–19950 recalls

FDA records 13 decisions for Bioclinical Systems, Inc. (St.Louis, MO) from 1985 to 1995: 13 510(k) clearances. Most are in product codes JTY (Culture Media, For Isolation Of Pathogenic…) and CEP (Radioimmunoassay, Luteinizing Hormone). 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 Bioclinical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bioclinical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Bioclinical”

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