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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 K171072
Device Name N Latex Cystatin C; N Protein Standard UY
Applicant
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring-Str. 76
Marburg,  DE 35041
Applicant Contact Christine Perkins
Correspondent
Siemens Healthcare Diagnostics Products GmbH
Emil-Von-Behring-Str. 76
Marburg,  DE 35041
Correspondent Contact Christine Perkins
Regulation Number862.1225
Classification Product Code
NDY  
Subsequent Product Code
JIX  
Date Received04/10/2017
Decision Date 05/12/2017
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
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