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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thin Layer Chromatography, Methamphetamine
510(k) Number K132630
Device Name WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
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 Number862.3610
Classification Product Code
DJC  
Subsequent Product Code
JXM  
Date Received08/22/2013
Decision Date 09/27/2013
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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