UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE— 510(k) K863442

Name: FDA 510(k) clearance K863442
Creator: U.S. Food and Drug Administration
Published: 1987-02-04

Substantially Equivalent

United Biotech, Inc.

FDA 510(k) clearance K863442 for UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE, Substantially Equivalent on 1987-02-04. Applicant: United Biotech, Inc.. Device class: 1.

Clearance details

Applicant: United Biotech, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1986-09-05
Decision date: 1987-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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