Cleared Traditional

MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP

K062575 · Princeton BioMeditech Corp. · Toxicology

Nov 2007

Decision

452d

Days

Class 2

Risk

About This 510(k) Submission

K062575 is an FDA 510(k) clearance for the MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, 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 November 26, 2007, 452 days after receiving the submission on August 31, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number	K062575 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 2006
Decision Date	November 26, 2007
Days to Decision	452 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF