Cleared Traditional

LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC

K014066 · Princeton BioMeditech Corp. · Toxicology
Jun 2002
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K014066 is an FDA 510(k) clearance for the LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), 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 862.3870.

Submission Details

510(k) Number K014066 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 LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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