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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, Tracrolimus
510(k) Number K050206
Device Name CEDIA TACROLIMUS 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 Number862.1678
Classification Product Code
MLM  
Subsequent Product Code
JIT  
Date Received01/28/2005
Decision Date 03/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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