LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC

Enzyme Immunoassay, Cannabinoids

PRINCETON BIOMEDITECH CORP.

The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Lifesign Thc, Status Stik Thc, Accusign Stik Thc, Lifesign Marijuana, Accustik Thc.

Pre-market Notification Details

Device IDK014066
510k NumberK014066
Device Name:LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC
ClassificationEnzyme Immunoassay, Cannabinoids
Applicant PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction,  NJ  08852 -1905
ContactJemo Kang
CorrespondentJemo Kang
PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction,  NJ  08852 -1905
Product CodeLDJ  
CFR Regulation Number862.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-10
Decision Date2002-06-10
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.