K222881
- 510(k) number
- K222881
- Device name
- Access hsTnI
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- MMI — Immunoassay Method, Troponin Subunit
- Decision date
- 2023-12-18
- Date received
- 2022-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K222881.pdf
Official FDA record: K222881
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.