Cleared Traditional

COMA COCAINE METABOLITE ASSAY (EIA)

K895043 · Serex, Inc. · Toxicology
Nov 1989
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K895043 is an FDA 510(k) clearance for the COMA COCAINE METABOLITE ASSAY (EIA), a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Serex, Inc. (Tenafly, US). The FDA issued a Cleared decision on November 8, 1989, 91 days after receiving the submission on August 9, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K895043 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 1989
Decision Date November 08, 1989
Days to Decision 91 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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