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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 K121610
Device Name COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY
Applicant
ROCHE DIAGNOSTICS OPERATIONS
9115 Hague Rd
Indianapolis,  IN  46256
Applicant Contact Susan Hollandbeck
Correspondent
ROCHE DIAGNOSTICS OPERATIONS
9115 Hague Rd
Indianapolis,  IN  46256
Correspondent Contact Susan Hollandbeck
Regulation Number862.1373
Classification Product Code
PDJ  
Date Received06/01/2012
Decision Date 08/08/2013
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
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