FDA applicant

Bio Spec, Inc.

Concord, CA3 decisions1984–19860 recalls

FDA records 3 decisions for Bio Spec, Inc. (Concord, CA) from 1984 to 1986: 3 510(k) clearances. Most are in product codes JTO (Discs, Strips And Reagents, Microorganism…) and GTP (Exoenzymes, Multiple, Streptococcal). 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, microbiology panel, where it files most

How often FDA has decided Bio Spec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio Spec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Bio Spec, Inc.

Which product codes does it file in?

What has FDA decided for it lately?