FDA applicant
The Binding Site Group, Ltd.
FDA records 44 decisions for The Binding Site Group, Ltd. (Birmingham, GB) from 2010 to 2025: 44 510(k) clearances. Most are in product codes CFN (Method, Nephelometric, Immunoglobulins (G, A, M)) and DFH (Kappa, Antigen, Antiserum, Control). Since 2016 its 510(k)s took a median of 70 days from receipt to decision, against 28 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 5 of them its own earlier devices. 13 recalls are linked to its devices.
FDA’s records also spell it “The Binding Site Group”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided The Binding Site Group, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like The Binding Site Group, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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