UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE— 510(k) K902897

Name: FDA 510(k) clearance K902897
Creator: U.S. Food and Drug Administration
Published: 1990-07-16

Substantially Equivalent

United Biotech, Inc.

FDA 510(k) clearance K902897 for UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE, Substantially Equivalent on 1990-07-16. Applicant: United Biotech, Inc.. Device class: 2.

Clearance details

Applicant: United Biotech, Inc.
Product code: Code LRM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1990-07-03
Decision date: 1990-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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