Source document or public record
FDA 510(k) K251564 — microINR System
FDA 510(k) index record K251564. Device: microINR System. Applicant as listed: Iline Microsystems, S.L.. Decision date: 2025-07-21.
Source
"device_name": "microINR System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K251564.
Device name: microINR System. Applicant as listed: Iline Microsystems, S.L..
Decision date: 2025-07-21. Decision wording: Substantially Equivalent.
Product code: GJS. Regulation: 21 CFR 864.7750. Medical specialty: Hematology.
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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