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510(k) K090920

HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) by The Binding Site, Ltd. — Product Code CFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2009
Date Received
April 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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