FDA applicant

Granbio, Inc.

Temecula, CA8 decisions1987–19960 recalls

FDA records 8 decisions for Granbio, Inc. (Temecula, CA) from 1987 to 1996: 8 510(k) clearances. Most are in product codes LJN (Antibody Igm, If, Epstein-Barr Virus) and LLM (Test, Antigen, Nuclear, Epstein-Barr Virus). 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 Granbio, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Granbio, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Granbio, Inc.

Which product codes does it file in?

What has FDA decided for it lately?