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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 K121291
Device Name TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
Original Applicant
ROCHE DIAGNOSTICS
9115 south hague road
indianapolis,  IN  46250
Original Contact susan hollandbeck
Regulation Number862.1373
Classification Product Code
PDJ  
Subsequent Product Code
LCP  
Date Received04/30/2012
Decision Date 05/23/2013
Decision de novo petitions granted (AN)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
FOI Item Approval Letter
FDA Review Decision Summary
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
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