Cleared Traditional

GENPRIME DRUGS OF ABUSE READER SYSTEM

K130082 · Genprime, Inc. · Chemistry

Dec 2013

Decision

340d

Days

Class 2

Risk

About This 510(k) Submission

K130082 is an FDA 510(k) clearance for the GENPRIME DRUGS OF ABUSE READER SYSTEM, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Genprime, Inc. (Oms River, US). The FDA issued a Cleared decision on December 20, 2013, 340 days after receiving the submission on January 14, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number	K130082 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 14, 2013
Decision Date	December 20, 2013
Days to Decision	340 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF