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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 K093175
Device Name WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
1 Congressional Dr.
Apt. C
Greenville,  DE  19807
Applicant Contact HOWARD MANN
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
1 Congressional Dr.
Apt. C
Greenville,  DE  19807
Correspondent Contact HOWARD MANN
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Code
JXN  
Date Received10/08/2009
Decision Date 08/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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