Cleared Traditional

ABUSCREEN ONLINE FOR COCAINE METABOLITE

K924113 · Roche Diagnostic Systems, Inc. · Toxicology

Dec 1992

Decision

137d

Days

Class 2

Risk

About This 510(k) Submission

K924113 is an FDA 510(k) clearance for the ABUSCREEN ONLINE FOR COCAINE METABOLITE, a Hemagglutination, Cocaine Metabolites (benzoylecgnonine) (Class II — Special Controls, product code DLN), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 28, 1992, 137 days after receiving the submission on August 13, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number	K924113 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 13, 1992
Decision Date	December 28, 1992
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement