K232057
- 510(k) number
- K232057
- Device name
- BÜHLMANN fCAL® turbo and CALEX® Cap
- Applicant
- Bühlmann Laboratories AG CH
- Product code
- NXO — Calprotectin, Fecal
- Decision date
- 2024-02-06
- Date received
- 2023-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232057.pdf
Official FDA record: K232057
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.