MMI
- Product code
- MMI
- Device name
- Immunoassay Method, Troponin Subunit
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1215
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 9
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 95 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (9)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253051 | 2026-06-11 | Abbott Point of Care, Inc. | i-STAT hs-TnI cartridge with the i-STAT Alinity Syst… | |
| K252393 | 2025-10-29 | Ortho-Clinical Diagnostics, Inc. | VITROS Immunodiagnostic Products hs Troponin I Reage… | |
| K243483 | 2025-08-01 | Beckman Coulter, Inc. | Access hsTnI | |
| K242870 | 2025-06-16 | Beckman Coulter, Inc. | Access hsTnI | |
| K240984 | 2025-01-03 | Abbott Point of Care, Inc. | i-STAT hs-TnI cartridge with the i-STAT 1 System | |
| K241165 | 2024-07-25 | Siemens Healthcare Diagnostics, Inc. | Atellica® IM High-Sensitivity Troponin I (TnIH) | |
| K231974 | 2024-03-20 | Phc Corporation | PATHFAST®hs-cTnI-II | |
| K222881 | 2023-12-18 | Beckman Coulter, Inc. | Access hsTnI | |
| K230648 | 2023-12-04 | Beckman Coulter, Inc. | Access hsTnI |
Official FDA classification page: MMI
Classification and pathway per current FDA publications. Data from openFDA (CC0).