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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, glycosylated hemoglobin
510(k) Number K102914
Device Name TQ HBA1C GEN3
Applicant
ROCHE
9115 HAGUE RD
INDIANAPOLIS,  IN  46250
Applicant Contact KATHIE J GOODWIN
Correspondent
ROCHE
9115 HAGUE RD
INDIANAPOLIS,  IN  46250
Correspondent Contact KATHIE J GOODWIN
Regulation Number864.7470
Classification Product Code
LCP  
Date Received10/01/2010
Decision Date 01/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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