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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, Opiates
510(k) Number K101754
Device Name THERMO SCIENTIFIC CEDIA OPIATE 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
Regulation Number862.3650
Classification Product Code
DJG  
Date Received06/22/2010
Decision Date 04/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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