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CLIA record K034069 and corresponding
510(K) Premarket Notification information

Test System NameRoche Diagnostics Hitachi 917  {Microgenics CEDIA Sirolimus Assay} 
Document Number K034069
Analyte Namesirolimus
Analyte SpecialtyToxicology / TDM
ComplexityHIGH
Effective Date05/03/2005

510(k) Premarket Notification Database

Device Classification Name sirolimus test system
510(k) NumberK034069
Device NameCEDIA SIROLIMUS ASSAY
Applicant
MICROGENICS CORP.
46360 fremont blvd.
fremont,  CA  94538
Contactdavid casal
Regulation Number862.3840
Classification Product Code
NRP
Date Received01/06/2004
Decision Date 06/15/2004
Decision cleared for marketing automatic class iii designat (AN)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
FOI ITEM LETTER
Type Cleared for Marketing Automatic Class III Designation
Reviewed by Third Party No
Expedited Review No

Database Updated 02/06/2009

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