Data / Medical devices / Switzerland / Abionic SA
Abionic SA: FDA-registered device maker in Epalinges Vaud, Switzerland, 1 510(k) clearance
Abionic SA is registered with the FDA (registration 3013960814) in Epalinges Vaud, Switzerland. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 25, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013960814
- Address
- Biopole, Building Alanine Route de la Corniche 5, Epalinges Vaud, Switzerland, CH-1066
- Owner or operator
- Abionic SA (10055862)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 13, 2017
- Registered through
- 2026
- Brand names listed
- AbioSCOPE, IVD CAPSULE Aeroallergens I, AbioSCOPE, IVD CAPSULE PSP, abioSCOPE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fluorometer, For Clinical Use | KHO | 1 | Manufacturer | accessdata.fda.gov |
| Immunoassay For Host Biomarkers Of Sepsis | SCX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens | PUW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 25, 2024 | K240041 | IVD CAPSULE PSP; abioSCOPE | SCX | Substantially Equivalent | Abionic SA | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens
- All makers of Fluorometer, For Clinical Use
Updated September 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.