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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme immunoassay, cocaine and cocaine metabolites
510(k) Number K121166
FOIA Releasable 510(k) 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
Correspondent Contact Joe Shia
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DJG   DJR   LAF   LCM   LFG  
Date Received04/17/2012
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
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