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510(k) K120169

INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT by Grifols USA, LLC — Product Code CFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2012
Date Received
January 19, 2012
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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