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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hemoglobin a1c test system
510(k) Number K160571
Device Name cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
Applicant
Roche Diagnostics Operations (RDO)
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact David Tribbett
Correspondent
Roche Diagnostics Operations (RDO)
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact David Tribbett
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Code
JJE  
Date Received02/29/2016
Decision Date 12/19/2016
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
Recalls CDRH Recalls
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