K231974
- 510(k) number
- K231974
- Device name
- PATHFAST®hs-cTnI-II
- Applicant
- Phc Corporation JP
- Product code
- MMI — Immunoassay Method, Troponin Subunit
- Decision date
- 2024-03-20
- Date received
- 2023-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231974.pdf
Official FDA record: K231974
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.