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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, Phencyclidine
510(k) Number K935650
Device Name CEDIA(R) DAU PCP ASSAY
Applicant
Microgenics Corp.
2380a Bisso Ln.
Concord,  CA  94520
Applicant Contact BETSY SOARES-MADDOX
Correspondent
Microgenics Corp.
2380a Bisso Ln.
Concord,  CA  94520
Correspondent Contact BETSY SOARES-MADDOX
Classification Product Code
LCM  
Date Received11/23/1993
Decision Date 04/05/1994
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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