FDA applicant

Biosure, Inc.

San Jose, CA1 decision1987–19870 recalls

FDA records 1 decision for Biosure, Inc. (San Jose, CA) in 1987: 1 510(k) clearance. All are in product code KDT (Container, Specimen Mailer And Storage, Sterile). 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, pathology panel, where it files most

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

FDA decisions per year

No FDA decision for Biosure, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Biosure, Inc.

Which product codes does it file in?

What has FDA decided for it lately?