K243483
- 510(k) number
- K243483
- Device name
- Access hsTnI
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- MMI — Immunoassay Method, Troponin Subunit
- Decision date
- 2025-08-01
- Date received
- 2024-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243483.pdf
Official FDA record: K243483
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.