WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST


Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K111560
Device Name WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
504 east diamond ave.
suite f
gaithersbrug, 
MD 
20878

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

Correspodent Contact joe shia
Regulation Number 862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIX   JXM  
Date Received 06/03/2011
Decision Date 07/15/2011
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