Rheumatoid Factor (RF) Kit for use on SPAPLUS— 510(k) K160070

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K160070 for Rheumatoid Factor (RF) Kit for use on SPAPLUS, Substantially Equivalent on 2016-12-07. Applicant: The Binding Site Group , Ltd..

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code DHR
Advisory panel: Immunology
Date received: 2016-01-13
Decision date: 2016-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edgbaston, GB

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