FDA applicant

Pacific Biotech, Inc.

San Diego, CA29 decisions1983–19930 recalls

FDA records 29 decisions for Pacific Biotech, Inc. (San Diego, CA) from 1983 to 1993: 29 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and GTZ (Antisera, All Groups, Streptococcus Spp.). 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 Pacific Biotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pacific Biotech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Pacific Biotech, Inc.

Which product codes does it file in?

What has FDA decided for it lately?