LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA


Device Classification Name

gas chromatography, methamphetamine

510(k) Number K023837
Device Name LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA
Original Applicant
PRINCETON BIOMEDITECH CORP.
4242 u.s. rt. 1
monmouth junction, 
NJ 
08852 -1905

Original Contact jemo kang
Regulation Number 862.3610
Classification Product Code
LAF  
Subsequent Product Codes
DIO   DJG   LDJ  
Date Received 11/18/2002
Decision Date 09/15/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No