510(k) K260613
- Device
- AMI™ Plasma Cartridge, AMI™
- Applicant
- Sequitur Health Corp.
- 510(k) number
- K260613
- Product code
- JID
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-01
- Date received
- 2026-02-25
- Regulation
- 862.1065
- Classification name
- Photometric Method, Ammonia
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Marylaura Thomas
- Address
- 6161 E Mayo Blvd. Suite 221d Phoenix AZ US 85054 85054
FDA Registration Numbers#
- 3000308930
- 3023591031
- 1319681
- 1319808
- 3012963943
- 3002642396
- 1319809
- 2250051