CAPI 3 HEMOGLOBIN(E)— 510(k) K180762

Substantially Equivalent

Sebia

FDA 510(k) clearance K180762 for CAPI 3 HEMOGLOBIN(E), Substantially Equivalent on 2018-12-14. Applicant: Sebia.

Clearance details

Applicant: Sebia
Product code: Code GKA
Advisory panel: Hematology
Date received: 2018-03-23
Decision date: 2018-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

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