K253051
- 510(k) number
- K253051
- Device name
- i-STAT hs-TnI cartridge with the i-STAT Alinity System
- Applicant
- Abbott Point of Care, Inc. NJ · US
- Product code
- MMI — Immunoassay Method, Troponin Subunit
- Decision date
- 2026-06-11
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253051.pdf
Official FDA record: K253051
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.