FDA applicant
United Biotech, Inc.
FDA records 22 decisions for United Biotech, Inc. (Mountain View, CA) from 1985 to 1998: 22 510(k) clearances. Most are in product codes DJG (Enzyme Immunoassay, Opiates) and JHI (Visual, Pregnancy Hcg, Prescription Use). 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 United Biotech, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for United Biotech, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like United Biotech, 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) Report