Data / Medical devices / United States / Sequitur Health Corp.
Sequitur Health Corp.: FDA-registered device maker in Phoenix, AZ, United States, 1 510(k) clearance
Sequitur Health Corp. is registered with the FDA (registration 3023591031) in Phoenix, AZ, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 1, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023591031
- Address
- 6161 E Mayo Blvd STE 221D, Phoenix, AZ, United States, 85054
- Owner or operator
- Sequitur Health Corp. (10094473)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- December 2, 2025
- Registered through
- 2026
- Brand names listed
- AMI, AMI Plasma Cartridge, AMI QC Level 1, AMI QC Level 2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Micro Pipette | JRC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Photometric Method, Ammonia | JID | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 1, 2026 | K260613 | AMI Plasma Cartridge, AMI | JID | Substantially Equivalent | Sequitur Health Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Photometric Method, Ammonia
- All makers of Micro Pipette
Updated September 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.