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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name immunoelectrophoretic, immunoglobulins, (g, a, m)
510(k) Number K002799
Device Name PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA,  CA  92822
Applicant Contact ANNETTE HELLIE
Correspondent
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA,  CA  92822
Correspondent Contact ANNETTE HELLIE
Regulation Number866.5510
Classification Product Code
CFF  
Date Received09/08/2000
Decision Date 10/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
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