Documento fuente o registro público
FDA 510(k) K240041 — IVD CAPSULE PSP; abioSCOPE
FDA 510(k) index record K240041. Device: IVD CAPSULE PSP; abioSCOPE. Applicant as listed: Abionic SA. Decision date: 2024-09-25.
Fuente
"device_name": "IVD CAPSULE PSP; abioSCOPE"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K240041.
Device name: IVD CAPSULE PSP; abioSCOPE. Applicant as listed: Abionic SA.
Decision date: 2024-09-25. Decision wording: Substantially Equivalent.
Product code: SCX. Regulation: 21 CFR 866.3215. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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