WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P


Device Classification Name

enzyme immunoassay, cocaine and cocaine metabolites

510(k) Number K112071
Device Name WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
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 862.3250
Classification Product Code
DIO  
Subsequent Product Code
LAF  
Date Received 07/20/2011
Decision Date 09/23/2011
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