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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 K013235
Device Name MODIFICATION TO SYNCHRON CONTROL
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA,  CA  92822
Applicant Contact MARY BETH TANG
Correspondent
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA,  CA  92822
Correspondent Contact MARY BETH TANG
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/28/2001
Decision Date 10/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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