WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST


Device Classification Name

radioimmunoassay, tricyclic antidepressant drugs

510(k) Number K112395
Device Name WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS 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 862.3910
Classification Product Code
LFG  
Subsequent Product Code
LCM  
Date Received 08/19/2011
Decision Date 09/09/2011
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