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Document NumberK130665
Test Name BTNX, Inc. Rapid Response Multi-Drug Urine Test Panel  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(888)339-9964
Test TypeBenzodiazepines
Effective Date12/05/2013
Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K130665
Device Name WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
504 E. Diamond Ave. Suite F
Gaithersburg,  MD  20878
Applicant Contact Joe Shia
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
504 E. Diamond Ave. Suite F
Gaithersburg,  MD  20878
Correspondent Contact Joe Shia
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIO   DIS   DKZ   JXM   LAF  
LCM   LDJ  
Date Received03/12/2013
Decision Date 04/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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