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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 (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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