CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name MK Bio Bionexia OptiCup DOA Test   Document Number K082977 Analyte Name Cocaine Metabolites Analyte Specialty Toxicology / TDM Complexity MODERATE Effective Date 08/24/2009 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 Contact jane zhang Regulation Number 862.3870 Classification Product Code LDJ   Subsequent Product Codes DIO   DIS   DJG   DJR   DKZ   JXM   LCM   LFG   Date Received 10/06/2008 Decision Date 08/20/2009 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Toxicology Review Advisory Committee Toxicology Statement/Summary/Purged Status Summary only summary summary FDA Review Decision Summary Type Special Reviewed by Third Party No Expedited Review No