UBI MAGIWEL COCAINE METABOLITES— 510(k) K973156

Name: FDA 510(k) clearance K973156
Creator: U.S. Food and Drug Administration
Published: 1997-10-28

Substantially Equivalent

United Biotech, Inc.

FDA 510(k) clearance K973156 for UBI MAGIWEL COCAINE METABOLITES, Substantially Equivalent on 1997-10-28. Applicant: United Biotech, Inc.. Device class: 2.

Clearance details

Applicant: United Biotech, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1997-08-22
Decision date: 1997-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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