K232027
- 510(k) number
- K232027
- Device name
- CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
- Applicant
- Sebia GA · US
- Product code
- GKA — Abnormal Hemoglobin Quantitation
- Decision date
- 2024-04-04
- Date received
- 2023-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232027.pdf
Official FDA record: K232027
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.