Cleared Traditional

COCAINE METABOLITE EIA TEST

K960187 · Diagnostic Reagents, Inc. · Toxicology
Apr 1996
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K960187 is an FDA 510(k) clearance for the COCAINE METABOLITE EIA TEST, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 2, 1996, 77 days after receiving the submission on January 16, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K960187 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 1996
Decision Date April 02, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

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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