Human IgM Kit for use on SPAPlus— 510(k) K191465

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K191465 for Human IgM Kit for use on SPAPlus, Substantially Equivalent on 2019-06-27. Applicant: The Binding Site Group , Ltd..

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code CFN
Advisory panel: Immunology
Date received: 2019-06-03
Decision date: 2019-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Edgbaston, GB

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