FDA applicant
Biopool Intl., Inc.
FDA records 4 decisions for Biopool Intl., Inc. (Ventura, CA) from 1998 to 2001: 4 510(k) clearances. Most are in product codes DAP (Fibrinogen And Fibrin Split Products, Antigen…) and LIM (Test, Screening, For D Positive Fetal Rbc'S). 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 Biopool Intl., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Biopool Intl., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Biopool Intl., 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 “Biopool”
FDA records each applicant name separately; these may or may not be the same firm.