Cleared Traditional

LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC

K014067 · Princeton BioMeditech Corp. · Toxicology
Jun 2002
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K014067 is an FDA 510(k) clearance for the LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on June 10, 2002, 182 days after receiving the submission on December 10, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K014067 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2001
Decision Date June 10, 2002
Days to Decision 182 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

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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