FDA applicant

Biocircuits Corp.

Sunnyvale, CA8 decisions1995–19980 recalls

FDA records 8 decisions for Biocircuits Corp. (Sunnyvale, CA) from 1995 to 1998: 8 510(k) clearances. Most are in product codes KLI (Enzyme Immunoassay, Non-Radiolabeled, Total…) and LTJ (Prostate-Specific Antigen (Psa) For Management…). 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 Biocircuits Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biocircuits Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biocircuits Corp.’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

Biocircuits Corp.

Which product codes does it file in?

What has FDA decided for it lately?