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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, amphetamine
510(k) Number K121987
Device Name WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
504 EAST DIAMOND AVE.
SUITE F GAITHERSBURG,  MD  20877
Applicant Contact Joe Shia
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
504 EAST DIAMOND AVE.
SUITE F GAITHERSBURG,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIS   JXM  
Date Received07/06/2012
Decision Date 08/01/2012
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
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