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Document NumberK151478
Test Name Guangzhou Wondfo Biotech Co., Ltd. Wondfo CR3 Keyless Split Sample Cup  (Cup System)
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(888)444-3657
Test TypePhencyclidine (PCP)
Effective Date07/07/2015
Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K151478
Device Name Wondfo CR3 Keyless Split Sample Cup
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  20877
Correspondent Contact JOE SHIA
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIO   DIS   DJR   DKZ   JXM  
LAF   LCM   LDJ   LFG  
Date Received06/02/2015
Decision Date 07/01/2015
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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