WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL


Device Classification Name

enzyme immunoassay, cocaine and cocaine metabolites

510(k) Number K121166
Device Name WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
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 862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DJG   DJR   LAF   LCM   LFG  
Date Received 04/17/2012
Decision Date 05/08/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized