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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 K140089
Device Name CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
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 Code
JXM  
Date Received01/14/2014
Decision Date 04/08/2014
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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