Cleared Traditional

ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P

K983147 · Princeton BioMeditech Corp. · Toxicology
Sep 1998
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K983147 is an FDA 510(k) clearance for the ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P, a Reagents, Test, Tetrahydrocannabinol (Class II — Special Controls, product code DKE), submitted by Princeton BioMeditech Corp. (Princeton, US). The FDA issued a Cleared decision on September 28, 1998, 20 days after receiving the submission on September 8, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K983147 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 1998
Decision Date September 28, 1998
Days to Decision 20 days
Submission Type Traditional
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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