510(k) Report

FDA applicant

United Biotech, Inc.

Mountain View, CA22 decisions1985–19980 recalls

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, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

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.

FIG. 1 — United Biotech, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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