K240041
- 510(k) number
- K240041
- Device name
- IVD CAPSULE PSP; abioSCOPE
- Applicant
- Abionic SA CH
- Product code
- SCX — Immunoassay For Host Biomarkers Of Sepsis
- Decision date
- 2024-09-25
- Date received
- 2024-01-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240041.pdf
Official FDA record: K240041
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.