CAPILLARYS Hb A1c— 510(k) K171861

Substantially Equivalent

Sebia

FDA 510(k) clearance K171861 for CAPILLARYS Hb A1c, Substantially Equivalent on 2018-02-07. Applicant: Sebia.

Clearance details

Applicant: Sebia
Product code: Code PDJ
Advisory panel: Clinical Chemistry
Date received: 2017-06-22
Decision date: 2018-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

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