COCAINE METABOLITE ENZYME IMMUNOASSAY KIT— 510(k) K871305

Name: FDA 510(k) clearance K871305
Creator: U.S. Food and Drug Administration
Published: 1987-06-05

Substantially Equivalent

General Diagnostics

FDA 510(k) clearance K871305 for COCAINE METABOLITE ENZYME IMMUNOASSAY KIT, Substantially Equivalent on 1987-06-05. Applicant: General Diagnostics. Device class: 2.

Clearance details

Applicant: General Diagnostics
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1987-04-01
Decision date: 1987-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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