FDA 510(k) clearance · back to tracker
AMI Plasma Cartridge, AMI
Sequitur Health Corp. cleared K260613 on 2026-09-01, decision: substantially equivalent
K-number
K260613
Sponsor
Sequitur Health Corp.
Device
AMI Plasma Cartridge, AMI
Class
Class I
Decision
Substantially Equivalent
Decision date
2026-09-01
Product code
JID
Advisory committee
Clinical Chemistry
Medical specialty
Clinical Chemistry
Regulation number
862.1065
Official FDA record
Open K260613on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
openFDA JSON
Raw record →
Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
Use this as a predicate
Drop K260613 into Compass and start a substantial-equivalence draft.
Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.
Try the sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.