Optilite Rheumatoid Factor Kit— 510(k) K162263

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K162263 for Optilite Rheumatoid Factor Kit, Substantially Equivalent on 2017-05-03. Applicant: The Binding Site Group , Ltd..

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code DHR
Advisory panel: Immunology
Date received: 2016-08-11
Decision date: 2017-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

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