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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
Models W19-CU, W19-P, W57-CU, W57-P
Device Name WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST
Original Applicant
GUANGZHOU WONDFO BIOTECH CO., LTD.
504 east diamond ave.
suite f gaithersburg,  MD  20877
Original 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 - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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