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510(k) K142735

The Optilite IgG3 kit by The Binding Site Group , Ltd. — Product Code CFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2014
Date Received
September 23, 2014
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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