510(k) clearance

AMI™ Plasma Cartridge, AMI™

FDA 510(k) source

510(k) number

K260613

Applicant

Sequitur Health Corp.

Decision date

Sep 1, 2026

Date received

Feb 25, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

JID

Device type

Photometric Method, Ammonia

Device class

Class I

Regulation

21 CFR 862.1065

Advisory committee

Clinical Chemistry

Statement or summary

Summary

Third party

N

Location

Phoenix, AZ, US