Cleared Traditional

AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY

K923314 · Serex, Inc. · Toxicology

Aug 1992

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K923314 is an FDA 510(k) clearance for the AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY, a Enzyme Immunoassay, Cocaine (Class II — Special Controls, product code JXO), submitted by Serex, Inc. (Maywood, US). The FDA issued a Cleared decision on August 24, 1992, 48 days after receiving the submission on July 7, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number	K923314 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 1992
Decision Date	August 24, 1992
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement