COMA COCAINE METABOLITE ASSAY (EIA)— 510(k) K895043

Name: FDA 510(k) clearance K895043
Creator: U.S. Food and Drug Administration
Published: 1989-11-08

Substantially Equivalent

Serex, Inc.

FDA 510(k) clearance K895043 for COMA COCAINE METABOLITE ASSAY (EIA), Substantially Equivalent on 1989-11-08. Applicant: Serex, Inc.. Device class: 2.

Clearance details

Applicant: Serex, Inc.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 1989-08-09
Decision date: 1989-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tenafly, NJ, US

Download summary PDF View on FDA.gov ↗

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