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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name hemoglobin a1c test system
De Novo Number DEN130002
510(K) Number K121291
Device Name TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
Requester
roche diagnostics
9115 s. hague rd.
indianapolis,  IN  46250
Contact susan hollandbeck
Regulation Number862.1373
Classification Product Code
PDJ  
Date Received03/25/2013
Decision Date 05/23/2013
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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