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510(k) K161854

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS by The Binding Site Group , Ltd. — Product Code PCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2016
Date Received
July 6, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoglobulin G Kappa Heavy And Light Chain Combined
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Intended for the in-vitro quantification of IgG kappa concentration in human serum.

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