AMI Plasma Cartridge, AMI— 510(k) K260613
Substantially EquivalentSequitur 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.
Summary
Sequitur Health Corp. filed the AMI Plasma Cartridge, AMI, under product code JID (Photometric Method, Ammonia). The record doesn't describe the cartridge beyond its name and code.
Class I, 21 CFR 862.1065. Clinical Chemistry is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Sequitur filed from Phoenix, Arizona. The decision came 188 calendar days after FDA received it (February 25 to September 1, 2026).
Clearance details
- Applicant
- Sequitur Health Corp.
- Product code
- Product code JID
- Device class
- Class 1
- Regulation
- 21 CFR 862.1065
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Phoenix, AZ, US
Recent devices under product code JID
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