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510(k) K152389

Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit by The Binding Site Group , Ltd. — Product Code PDE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2015
Date Received
August 24, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoglobulin M 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 IgM kappa concentration in human serum. The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.

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Other clearances for product code PDE

  • K140686 — HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS (August 6, 2014)