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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 K140829
Device Name UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
Applicant
BECKMAN COULTER, INC.
250 S. KRAEMER BLVD.
MAIL STOP E1.SE.01
BREA,  CA  92821
Applicant Contact ANNETTE HELLIE
Correspondent
BECKMAN COULTER, INC.
250 S. KRAEMER BLVD.
MAIL STOP E1.SE.01
BREA,  CA  92821
Correspondent Contact ANNETTE HELLIE
Regulation Number864.7470
Classification Product Code
LCP  
Date Received04/01/2014
Decision Date 07/14/2014
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
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