Source document or public record
FDA 510(k) K260613 — AMI Plasma Cartridge, AMI
FDA 510(k) index record K260613. Device: AMI Plasma Cartridge, AMI. Applicant as listed: Sequitur Health Corp.. Decision date: 2026-09-01.
Source
"device_name": "AMI Plasma Cartridge, AMI"
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
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FDA 510(k) public index record K260613.
Device name: AMI Plasma Cartridge, AMI. Applicant as listed: Sequitur Health Corp..
Decision date: 2026-09-01. Decision wording: Substantially Equivalent.
Product code: JID. Regulation: 21 CFR 862.1065. Medical specialty: Clinical Chemistry.
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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