DeviceClearance

CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument— 510(k) K232027

Substantially Equivalent

Sebia

FDA 510(k) clearance K232027 for CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument, Substantially Equivalent on 2024-04-04. Applicant: Sebia.

Clearance details

Applicant
Sebia
Product code
Code GKA
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Norcross, GA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.