FDA applicant
Alfa Scientific Designs, Inc.
FDA records 44 decisions for Alfa Scientific Designs, Inc. (Poway, CA) from 1999 to 2026: 44 510(k) clearances. Most are in product codes DKZ (Enzyme Immunoassay, Amphetamine) and JHI (Visual, Pregnancy Hcg, Prescription Use). Its devices cite 37 predicates, 15 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
How often FDA has decided Alfa Scientific Designs, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Alfa Scientific Designs, 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) ReportOther applicant names beginning “Alfa”
FDA records each applicant name separately; these may or may not be the same firm.