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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, Cocaine And Cocaine Metabolites
510(k) Number K941310
Device Name CEDIA DAU COCAINE ASSAY
Applicant
Microgenics Corp.
2400 Bisso Ln.
Concord,  CA  94520
Applicant Contact Patricia Klimley
Correspondent
Microgenics Corp.
2400 Bisso Ln.
Concord,  CA  94520
Correspondent Contact Patricia Klimley
Regulation Number862.3250
Classification Product Code
DIO  
Date Received03/14/1994
Decision Date 06/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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