Source document or public record
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.
Source
"device_name": "IVD CAPSULE PSP; abioSCOPE"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
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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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