Documento fuente o registro público
FDA 510(k) K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
FDA 510(k) index record K232027. Device: CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument. Applicant as listed: Sebia. Decision date: 2024-04-04.
Fuente
"device_name": "CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-27
professional use
FDA 510(k) public index record K232027.
Device name: CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument. Applicant as listed: Sebia.
Decision date: 2024-04-04. Decision wording: Substantially Equivalent.
Product code: GKA. Regulation: 21 CFR 864.7415. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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