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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 K131307
Device Name ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 BENEDICT AVE
TARRYTOWN,  NY  10591
Applicant Contact KIRA GORDON
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 BENEDICT AVE
TARRYTOWN,  NY  10591
Correspondent Contact KIRA GORDON
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JIT  
Date Received05/07/2013
Decision Date 01/24/2014
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
Recalls CDRH Recalls
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