K231601
- 510(k) number
- K231601
- Device name
- FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
- Applicant
- Sebia GA · US
- Product code
- DFH — Kappa, Antigen, Antiserum, Control
- Decision date
- 2024-02-23
- Date received
- 2023-06-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231601.pdf
Official FDA record: K231601
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.