AMI™ Plasma Cartridge, AMI™

FDA 510(k) K260613 · Sequitur Health Corp.

Substantially Equivalent

510(k) numberK260613

Submission

Device name
AMI™ Plasma Cartridge, AMI™
Applicant
Sequitur Health Corp.
Phoenix, AZ, US
Received
February 25, 2026
Decision date
September 1, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JID – Photometric Method, Ammonia
Device class
Class I (low risk)
Regulation
21 CFR 862.1065
Specialty
Clinical Chemistry

Other 510(k)s with product code JID

510(k)DeviceApplicantDecision
K991371Careside AmmoniaJID · Traditional Careside, Inc.08/03/1999SE
K820723Kodak Ektachem Clinical Chem. NH3JID · Traditional Eastman Kodak Company04/01/1982SE
K813366Ammonia TestJID · Traditional Wako Pure Chemical Industries, Ltd.12/22/1981SE

Questions and answers

When was AMI™ Plasma Cartridge, AMI™ cleared by the FDA?

AMI™ Plasma Cartridge, AMI™ (K260613) received a 510(k) decision of Substantially Equivalent on September 1, 2026, 188 days after the submission was received.

What is the product code of K260613?

The FDA product code is JID – Photometric Method, Ammonia, a Class I (low risk) device regulated under 21 CFR 862.1065.