AMI Plasma Cartridge, AMI— 510(k) K260613

Name: FDA 510(k) clearance K260613
Creator: U.S. Food and Drug Administration
Published: 2026-09-01

Substantially Equivalent

Sequitur Health Corp.

FDA 510(k) clearance K260613 for AMI Plasma Cartridge, AMI, Substantially Equivalent on 2026-09-01. Applicant: Sequitur Health Corp.. Device class: 1.

Clearance details

Applicant: Sequitur Health Corp.
Product code: Code JID
Device class: Class 1
Regulation: 21 CFR 862.1065
Advisory panel: Clinical Chemistry
Date received: 2026-02-25
Decision date: 2026-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

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