510(k) K240041
- Device
- IVD CAPSULE PSP; abioSCOPE
- Applicant
- Abionic SA
- 510(k) number
- K240041
- Product code
- SCX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-25
- Date received
- 2024-01-05
- Regulation
- 866.3215
- Classification name
- Immunoassay For Host Biomarkers Of Sepsis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Iwan Märki
- Address
- Rte. De La Corniche 5 Epalinges CH 1066 1066
FDA Registration Numbers#
- 3013960814