Cleared Traditional

IL TEST(TM) COCAINE

K913737 · Instrumentation Laboratory CO · Toxicology
Dec 1991
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K913737 is an FDA 510(k) clearance for the IL TEST(TM) COCAINE, a Enzyme Immunoassay, Cocaine (Class II — Special Controls, product code JXO), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 3, 1991, 105 days after receiving the submission on August 20, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K913737 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1991
Decision Date December 03, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

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

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