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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 K110934
Device Name ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
Applicant
Siemens Healthcare Diagnostics
333 Coney St.
East Walpole,,  MA  02032 -1516
Applicant Contact Sandra D White
Correspondent
Siemens Healthcare Diagnostics
333 Coney St.
East Walpole,,  MA  02032 -1516
Correspondent Contact Sandra D White
Regulation Number864.7470
Classification Product Code
LCP  
Date Received04/04/2011
Decision Date 08/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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