UBI MAGIWEL(TM) ANA QUANTITATIVE— 510(k) K910033

Name: FDA 510(k) clearance K910033
Creator: U.S. Food and Drug Administration
Published: 1991-01-25

Substantially Equivalent

United Biotech, Inc.

FDA 510(k) clearance K910033 for UBI MAGIWEL(TM) ANA QUANTITATIVE, Substantially Equivalent on 1991-01-25. Applicant: United Biotech, Inc.. Device class: 2.

Clearance details

Applicant: United Biotech, Inc.
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1991-01-04
Decision date: 1991-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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