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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, cannabinoids
510(k) Number K121557
Device Name WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE 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 Number862.3870
Classification Product Code
LDJ  
Subsequent Product Code
JXN  
Date Received05/25/2012
Decision Date 07/25/2012
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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