UBI MAGIWEL(TM) FSH QUANTITATIVE— 510(k) K864080

Name: FDA 510(k) clearance K864080
Creator: U.S. Food and Drug Administration
Published: 1986-11-13

Substantially Equivalent

United Biotech, Inc.

FDA 510(k) clearance K864080 for UBI MAGIWEL(TM) FSH QUANTITATIVE, Substantially Equivalent on 1986-11-13. Applicant: United Biotech, Inc.. Device class: 1.

Clearance details

Applicant: United Biotech, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1986-10-20
Decision date: 1986-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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