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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 K120199
Device Name GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY
Applicant
BECKMAN COULTER, INC
250 S. KRAEMER BLVD
MAIL STOP A2 SW. 08
BREA,  CA  92821
Applicant Contact BEVERLY HARDING
Correspondent
BECKMAN COULTER, INC
250 S. KRAEMER BLVD
MAIL STOP A2 SW. 08
BREA,  CA  92821
Correspondent Contact BEVERLY HARDING
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JIT  
Date Received01/23/2012
Decision Date 10/12/2012
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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