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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 K161817
Device Name Tina-quant Cystatin C Gen.2
Applicant
Roche Diagnostics Operations (Rdo)
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact Patrick Stimart
Correspondent
Roche Diagnostics Operations (Rdo)
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact Patrick Stimart
Regulation Number862.1225
Classification Product Code
NDY  
Date Received07/01/2016
Decision Date 07/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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