GENPRIME DRUGS OF ABUSE READER SYSTEM— 510(k) K130082

Name: FDA 510(k) clearance K130082
Creator: U.S. Food and Drug Administration
Published: 2013-12-20

Substantially Equivalent

Genprime, Inc.

FDA 510(k) clearance K130082 for GENPRIME DRUGS OF ABUSE READER SYSTEM, Substantially Equivalent on 2013-12-20. Applicant: Genprime, Inc.. Device class: 2.

Clearance details

Applicant: Genprime, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2013-01-14
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oms River, NJ, US

Download summary PDF View on FDA.gov ↗

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