Cleared Special

STATUS CUP ACCUSIGN CUP

K991751 · Princeton BioMeditech Corp. · Toxicology
Jun 1999
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K991751 is an FDA 510(k) clearance for the STATUS CUP ACCUSIGN CUP, 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 June 18, 1999, 25 days after receiving the submission on May 24, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K991751 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1999
Decision Date June 18, 1999
Days to Decision 25 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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