Cleared Traditional

AUTOMATES COMA COCAINE METABOLITE ASSAY

K921834 · Serex, Inc. · Toxicology
Jun 1992
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K921834 is an FDA 510(k) clearance for the AUTOMATES COMA COCAINE METABOLITE ASSAY, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Serex, Inc. (Maywood, US). The FDA issued a Cleared decision on June 15, 1992, 60 days after receiving the submission on April 16, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K921834 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 1992
Decision Date June 15, 1992
Days to Decision 60 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

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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