FDA applicant
Hillcrest Biologicals
FDA records 33 decisions for Hillcrest Biologicals (Cypress, CA) from 1983 to 1992: 33 510(k) clearances. Most are in product codes LSR (Reagent, Borrelia Serological Reagent) and GNK (Antisera, Cf, Echovirus 1-34). 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 Hillcrest Biologicals’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Hillcrest Biologicals since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hillcrest Biologicals’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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