Source document or public record
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.
Source
"device_name": "CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.