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510(k) K172613

Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit by The Binding Site Group , Ltd. — Product Code PCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2018
Date Received
August 31, 2017
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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Other clearances for product code PCN

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