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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photometric Method, Ammonia
510(k) Number K260613
Device Name AMI™ Plasma Cartridge, AMI™
Applicant
Sequitur Health Corp.
6161 E Mayo Blvd.
Suite 221d
Phoenix,  AZ  85054
Applicant Contact Marylaura Thomas
Correspondent
Sequitur Health Corp.
6161 E Mayo Blvd.
Suite 221d
Phoenix,  AZ  85054
Correspondent Contact Marylaura Thomas
Regulation Number862.1065
Classification Product Code
JID  
Subsequent Product Code
JJE  
Date Received02/25/2026
Decision Date 09/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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