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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K110251
Device Name SYNCHRON MULTI CALIBRATOR
Applicant
BECKMAN COULTER, INC.
250 S. KRAEMER BOULEVARD
MAIL STOP E2 SE08
BREA,  CA  92821
Applicant Contact Yvette Lloyd
Correspondent
BECKMAN COULTER, INC.
250 S. KRAEMER BOULEVARD
MAIL STOP E2 SE08
BREA,  CA  92821
Correspondent Contact Yvette Lloyd
Regulation Number862.1150
Classification Product Code
JIX  
Date Received01/28/2011
Decision Date 05/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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