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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
Applicant
BECKMAN COULTER, INC.
250 SOUTH KRAEMER BLVD
A2.SW.09
BREA,  CA  92822
Applicant Contact ANNETTE HELLIE
Correspondent
BECKMAN COULTER, INC.
250 SOUTH KRAEMER BLVD
A2.SW.09
BREA,  CA  92822
Correspondent 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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