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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, Barbiturate
510(k) Number K143535
Device Name CR3 Keyless Split Sample Cup Secobarbital- Methadone
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
Wondfo Scientech Park, S.
China Univ. Of Technology
Guangzhou,  CN 510641
Applicant Contact Ben Chen
Correspondent
LSI International, Inc.
504 E. Diamond Ave. Suite F
Gaithersburg,  MD  20878
Correspondent Contact Joe Shia
Regulation Number862.3150
Classification Product Code
DIS  
Subsequent Product Code
DJR  
Date Received12/15/2014
Decision Date 01/13/2015
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
Predetermined Change
Control Plan Authorized		 No
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