WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST


Device Classification Name

gas chromatography, methamphetamine

510(k) Number K112236
Device Name WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
504 east diamond ave.
suite f
gaithersburg, 
MD 
20878

Applicant Contact joe shia
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
504 east diamond ave.
suite f
gaithersburg, 
MD 
20878

Correspodent Contact joe shia
Regulation Number 862.3610
Classification Product Code
LAF  
Subsequent Product Code
DJG  
Date Received 08/04/2011
Decision Date 09/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No