COCAINE METABOLITE EIA ASSAY MODIFICATION— 510(k) K935016

Name: FDA 510(k) clearance K935016
Creator: U.S. Food and Drug Administration
Published: 1993-12-03

Substantially Equivalent

Diagnostic Reagents, Inc.

FDA 510(k) clearance K935016 for COCAINE METABOLITE EIA ASSAY MODIFICATION, Substantially Equivalent on 1993-12-03. Applicant: Diagnostic Reagents, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Reagents, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1993-10-18
Decision date: 1993-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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