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

Name: FDA 510(k) clearance K232027
Creator: U.S. Food and Drug Administration
Published: 2024-04-04

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. Device class: 2.

Clearance details

Applicant: Sebia
Product code: Code GKA
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 2023-07-07
Decision date: 2024-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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