510(k) K152389— Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit

Substantially Equivalent

The Binding Site Group , Ltd.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code PDE
Advisory panel: Immunology
Date received: 2015-08-24
Decision date: 2015-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

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