WONDFO METHADONE URINE TEST,OPIATE TEST


Device Classification Name

enzyme immunoassay, opiates

510(k) Number K112310
Device Name WONDFO METHADONE URINE TEST,OPIATE 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 862.3650
Classification Product Code
DJG  
Subsequent Product Code
DJR  
Date Received 08/10/2011
Decision Date 09/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No