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510(k) K120056

HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER by The Binding Site Group , Ltd. — Product Code DFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2013
Date Received
January 9, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kappa, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

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