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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 K121492
Device Name UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
Original Applicant
BECKMAN COULTER, INC.
250 south kraemer blvd
a2.sw.09
brea,  CA  92822
Original Contact annette hellie
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
KRZ  
Date Received05/21/2012
Decision Date 09/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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