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510(k) K103757

IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT by Grifols — Product Code CFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2011
Date Received
December 23, 2010
Clearance Type
Traditional
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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