Cleared Traditional

STATUS DS OXY

K130650 · Princeton BioMeditech Corp. · Toxicology
Feb 2014
Decision
352d
Days
Class 2
Risk

About This 510(k) Submission

K130650 is an FDA 510(k) clearance for the STATUS DS OXY, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on February 26, 2014, 352 days after receiving the submission on March 11, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K130650 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2013
Decision Date February 26, 2014
Days to Decision 352 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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