CAPI 3 Hb A1c— 510(k) K171537

Substantially Equivalent

Sebia

FDA 510(k) clearance K171537 for CAPI 3 Hb A1c, Substantially Equivalent on 2017-09-12. Applicant: Sebia.

Clearance details

Applicant: Sebia
Product code: Code PDJ
Advisory panel: Clinical Chemistry
Date received: 2017-05-25
Decision date: 2017-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.