FDA applicant
Gold Standard Diagnostics
FDA records 15 decisions for Gold Standard Diagnostics (Davis, CA) from 2012 to 2025: 15 510(k) clearances. Most are in product codes LSR (Reagent, Borrelia Serological Reagent) and GMQ (Antigens, Nontreponemal, All). Since 2016 its 510(k)s took a median of 133 days from receipt to decision, against 133 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Gold Standard Diagnostics, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Gold Standard Diagnostics’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Gold Standard Diagnostics’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) ReportOther applicant names beginning “Gold”
FDA records each applicant name separately; these may or may not be the same firm.