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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 K101746
Device Name THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
Applicant
Microgenics Corp.
46360 Fremont Blvd.
Fremont Blvd.,  CA  94538
Applicant Contact LISA CHARTER
Correspondent
Microgenics Corp.
46360 Fremont Blvd.
Fremont Blvd.,  CA  94538
Correspondent Contact LISA CHARTER
Classification Product Code
LCM  
Date Received06/22/2010
Decision Date 04/08/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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