Cleared Traditional

STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE

K062565 · Princeton BioMeditech Corp. · Chemistry
Feb 2007
Decision
173d
Days
Class 1
Risk

About This 510(k) Submission

K062565 is an FDA 510(k) clearance for the STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE, a Enzyme Immunoassay, Nicotine And Nicotine Metabolites (Class I — General Controls, product code MKU), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on February 20, 2007, 173 days after receiving the submission on August 31, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3220.

Submission Details

510(k) Number K062565 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2006
Decision Date February 20, 2007
Days to Decision 173 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MKU — Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3220

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