K241165
- 510(k) number
- K241165
- Device name
- Atellica® IM High-Sensitivity Troponin I (TnIH)
- Applicant
- Siemens Healthcare Diagnostics, Inc. DE · US
- Product code
- MMI — Immunoassay Method, Troponin Subunit
- Decision date
- 2024-07-25
- Date received
- 2024-04-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K241165.pdf
Official FDA record: K241165
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.