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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 E Diamond Ave.
Gaithersburg,  MD  20877
Applicant Contact Joe Shia
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
504 E Diamond Ave.
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
Predetermined Change
Control Plan Authorized		 No
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