Cleared Traditional

COCAINE DIPSTICK TEST, MODEL D747-A

K010239 · Teco Diagnostics · Toxicology
Jun 2001
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K010239 is an FDA 510(k) clearance for the COCAINE DIPSTICK TEST, MODEL D747-A, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on June 25, 2001, 151 days after receiving the submission on January 25, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K010239 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2001
Decision Date June 25, 2001
Days to Decision 151 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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