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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
Original Applicant
BECKMAN COULTER, INC.
200 south kraemer blvd. w-110
brea,  CA  92822
Original Contact annette hellie
Regulation Number866.5510
Classification Product Code
CFF  
Date Received09/08/2000
Decision Date 10/05/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Immunology
Review Advisory Committee Clinical Chemistry
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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