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510(k) K002799

PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 by Beckman Coulter, Inc. — Product Code CFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2000
Date Received
September 8, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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