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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.
Indianapolos,  IN  46250
Applicant Contact KATHIE J GOODWIN
Correspondent
Roche
9115 Hague Rd.
Indianapolos,  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
Predetermined Change
Control Plan Authorized		 No
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