Cleared Special

ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8

K991078 · Princeton BioMeditech Corp. · Toxicology
Apr 1999
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K991078 is an FDA 510(k) clearance for the ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8, 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 April 15, 1999, 20 days after receiving the submission on March 26, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K991078 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1999
Decision Date April 15, 1999
Days to Decision 20 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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