FDA applicant
Quidel Corp.
FDA records 131 decisions for Quidel Corp. (San Diego, CA) from 1983 to 2024: 128 510(k) clearances, 2 De Novo grants and 1 original PMA approval. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Since 2016 its 510(k)s took a median of 99 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 62 predicates, 34 of them its own earlier devices. 7 recalls are linked to its devices.
FDA’s records also spell it “Quidel Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Quidel Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Quidel Corp.’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 “Quidel”
FDA records each applicant name separately; these may or may not be the same firm.