FDA applicant

Affinity Biologicals, Inc.

Ancaster, Ontario, CA5 decisions2005–20160 recalls

FDA records 5 decisions for Affinity Biologicals, Inc. (Ancaster, Ontario, CA) from 2005 to 2016: 5 510(k) clearances. Most are in product codes GGN (Plasma, Coagulation Control) and GGP (Test, Qualitative And Quantitative Factor…). Its devices cite 7 predicates, 0 of them its own earlier devices. 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, hematology panel, where it files most

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

FDA decisions per year

1in 2016

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Affinity Biologicals, Inc.’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

Other applicant names beginning “Affinity”

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

Affinity Biosensors, LLC 3 Affinity Medical Technologies, LLC 1

Affinity Biologicals, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Affinity”