UBI MAGIWEL RF-IGM QUANTITATIVE— 510(k) K883355

Name: FDA 510(k) clearance K883355
Creator: U.S. Food and Drug Administration
Published: 1988-09-07

Substantially Equivalent

United Biotech, Inc.

FDA 510(k) clearance K883355 for UBI MAGIWEL RF-IGM QUANTITATIVE, Substantially Equivalent on 1988-09-07. Applicant: United Biotech, Inc.. Device class: 2.

Clearance details

Applicant: United Biotech, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1988-08-09
Decision date: 1988-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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