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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 K122961
Device Name WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
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 Code
LAF  
Date Received09/25/2012
Decision Date 12/21/2012
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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