FDA applicant

Precision Biologic

Dartmouth, N.S., CA17 decisions1999–20250 recalls

FDA records 17 decisions for Precision Biologic (Dartmouth, N.S., CA) from 1999 to 2025: 17 510(k) clearances. Most are in product codes GGP (Test, Qualitative And Quantitative Factor…) and GJT (Plasma, Coagulation Factor Deficient). Its devices cite 14 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Precision Biologic, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

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

FDA decisions per year

1in 2025

2007high 2 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Precision Biologic

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?