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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, Cannabinoids
510(k) Number K082977
Device Name BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP
Applicant
Mk Bio, Inc.
10239 Flanders Ct.
San Diego,  CA  92121
Applicant Contact Jane Zhang
Correspondent
Mk Bio, Inc.
10239 Flanders Ct.
San Diego,  CA  92121
Correspondent Contact Jane Zhang
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIO   DIS   DJG   DJR   DKZ  
JXM   LCM   LFG  
Date Received10/06/2008
Decision Date 08/20/2009
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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