510(k) clearances

AMI™ Plasma Cartridge, AMI™

Sequitur Health Corp. · Clinical Chemistry

K260613Substantially EquivalentTraditionalJID
Open FDA's page for this record
Third party flag
N
City
Phoenix
Advisory committee description
Clinical Chemistry
Address 1
6161 E Mayo Blvd.
Address 2
Suite 221d
Statement or summary
Summary
Product code
JID
Zip code
85054
Applicant
Sequitur Health Corp.
Decision date
2026-09-01
Decision code
SESE
Country code
US
Device name
AMI™ Plasma Cartridge, AMI™
Advisory committee
CH
Contact
Marylaura Thomas
K number
K260613
State
AZ
Date received
2026-02-25
Review advisory committee
CH
Postal code
85054
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Photometric Method, Ammonia
Medical specialty description
Clinical Chemistry
Regulation number
862.1065
Device class
1
Registration number
3012963943, 1319681, 3000308930, 1319808, 1319809, 3002642396, 2250051, 3023591031
FEI number
3012963943, 3000308930, 1000305840, 1000305841, 1000136573, 3002642396, 2250051, 3023591031
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.