IVD CAPSULE PSP; abioSCOPE— 510(k) K240041
Substantially EquivalentAbionic SA
FDA 510(k) clearance K240041 for IVD CAPSULE PSP; abioSCOPE, Substantially Equivalent on 2024-09-25. Applicant: Abionic SA. Device class: 2.
Clearance details
- Applicant
- Abionic SA
- Product code
- Code SCX
- Device class
- Class 2
- Regulation
- 21 CFR 866.3215
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Epalinges, CH
Data sourced from openFDA. This site is unofficial and independent of the FDA.