Cleared Special

ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/

K990786 · Princeton BioMeditech Corp. · Toxicology

Mar 1999

Decision

16d

Days

Class 2

Risk

About This 510(k) Submission

K990786 is an FDA 510(k) clearance for the ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/, a High Pressure Liquid Chromatography, Methamphetamine (Class II — Special Controls, product code LAG), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on March 26, 1999, 16 days after receiving the submission on March 10, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number	K990786 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 1999
Decision Date	March 26, 1999
Days to Decision	16 days
Submission Type	Special
Review Panel	Toxicology (TX)
Summary	Statement