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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K003488
Device Name SYNCHRON CONTROL
Applicant
BECKMAN COULTER, INC.
200 S. KRAEMER BLVD.,M/S W-104
BOX 8000
BREA,  CA  92822 -8000
Applicant Contact GAIL LEFEBVRE
Correspondent
BECKMAN COULTER, INC.
200 S. KRAEMER BLVD.,M/S W-104
BOX 8000
BREA,  CA  92822 -8000
Correspondent Contact GAIL LEFEBVRE
Regulation Number862.1660
Classification Product Code
JJY  
Date Received11/13/2000
Decision Date 11/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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