FDA applicant

Beacon Biologicals, Inc.

Boca Raton, FL1 decision2000–20000 recalls

FDA records 1 decision for Beacon Biologicals, Inc. (Boca Raton, FL) in 2000: 1 510(k) clearance. All are in product code GMQ (Antigens, Nontreponemal, All). 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 Beacon Biologicals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Beacon Biologicals, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Beacon”

FDA records each applicant name separately; these may or may not be the same firm.

Beacon Laboratories, Inc. 18 Beacon Biosignals, Inc. 4 Beacon Converters, Inc. 2 Beacon Surgical, Inc. 2 Beacon Endoscopic 1

Beacon Biologicals, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Beacon”