LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC— 510(k) K014067

Name: FDA 510(k) clearance K014067
Creator: U.S. Food and Drug Administration
Published: 2002-06-10

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K014067 for LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC, Substantially Equivalent on 2002-06-10. Applicant: Princeton BioMeditech Corp.. Device class: 2.

Clearance details

Applicant: Princeton BioMeditech Corp.
Product code: Code DIO
Device class: Class 2
Regulation: 21 CFR 862.3250
Advisory panel: Clinical Toxicology
Date received: 2001-12-10
Decision date: 2002-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monmouth Junction, NJ, US

Download summary PDF View on FDA.gov ↗

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