K252393
- 510(k) number
- K252393
- Device name
- VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
- Applicant
- Ortho-Clinical Diagnostics, Inc. NY · US
- Product code
- MMI — Immunoassay Method, Troponin Subunit
- Decision date
- 2025-10-29
- Date received
- 2025-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252393.pdf
Official FDA record: K252393
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.