510(k) K260613
K260613 is an FDA 510(k) premarket notification submitted by Sequitur Health Corp. for the device "AMI Plasma Cartridge, AMI". The FDA issued a decision of Substantially Equivalent on September 1, 2026. The device falls under product code JID (Photometric Method, Ammonia), a Class I device regulated under 21 CFR 862.1065.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2026
- Date Received
- February 25, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Photometric Method, Ammonia
- Device Class
- Class I
- Regulation Number
- 862.1065
- Review Panel
- CH
- Submission Type