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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, opiates
510(k) Number K113624
Device Name WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
Original Applicant
Guangzhou Wondfo Biotech Co., Ltd.
504 east diamond ave
suite f
gaithersburg,  MD  20878
Original Contact joe shia
Regulation Number862.3650
Classification Product Code
DJG  
Date Received12/08/2011
Decision Date 03/12/2012
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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