Cleared Special

STATUS STIK, ACCUSIGN STIK

K992068 · Princeton BioMeditech Corp. · Toxicology
Jul 1999
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K992068 is an FDA 510(k) clearance for the STATUS STIK, ACCUSIGN STIK, a Reagents, Test, Tetrahydrocannabinol (Class II — Special Controls, product code DKE), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on July 6, 1999, 18 days after receiving the submission on June 18, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K992068 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1999
Decision Date July 06, 1999
Days to Decision 18 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DKE — Reagents, Test, Tetrahydrocannabinol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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