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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, Methadone
510(k) Number K954227
Device Name CEDIA DAU METHADONE ASSAY
Applicant
Microgenics Corp.
2400 Bisso Ln.
P.O. Box 4117
Concord,  CA  94524
Applicant Contact MARY KONING
Correspondent
Microgenics Corp.
2400 Bisso Ln.
P.O. Box 4117
Concord,  CA  94524
Correspondent Contact MARY KONING
Regulation Number862.3620
Classification Product Code
DJR  
Date Received09/11/1995
Decision Date 11/17/1995
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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