UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE— 510(k) K864174

Substantially Equivalent

United Biotech, Inc.

FDA 510(k) clearance K864174 for UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE, Substantially Equivalent on 1987-03-13. Applicant: United Biotech, Inc..

Clearance details

Applicant: United Biotech, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1986-10-24
Decision date: 1987-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.