FDA applicant

San Diego Biotech

San Diego, CA2 decisions1998–19980 recalls

FDA records 2 decisions for San Diego Biotech (San Diego, CA) in 1998: 2 510(k) clearances. All are in product code JHI (Visual, Pregnancy Hcg, Prescription Use). 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 San Diego Biotech’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for San Diego Biotech since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like San Diego Biotech’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

San Diego Biotech

Which product codes does it file in?

What has FDA decided for it lately?