UBI MAGIWEL CMV IGG QUANTITATIVE— 510(k) K883399

Name: FDA 510(k) clearance K883399
Creator: U.S. Food and Drug Administration
Published: 1989-03-27

Substantially Equivalent

United Biotech, Inc.

FDA 510(k) clearance K883399 for UBI MAGIWEL CMV IGG QUANTITATIVE, Substantially Equivalent on 1989-03-27. Applicant: United Biotech, Inc.. Device class: 2.

Clearance details

Applicant: United Biotech, Inc.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1988-08-11
Decision date: 1989-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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