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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Cystatin C
510(k) Number K083906
Device Name ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487
Applicant
Siemens Healthcare Diagnostics
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact KIRA GORDON
Correspondent
Siemens Healthcare Diagnostics
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact KIRA GORDON
Regulation Number862.1225
Classification Product Code
NDY  
Subsequent Product Code
JIT  
Date Received12/30/2008
Decision Date 03/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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
Recalls CDRH Recalls
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