K242952
- 510(k) number
- K242952
- Device name
- INNOVANCE Antithrombin
- Applicant
- Siemens Healthcare Diagnostic Products GmbH DE
- Product code
- JBQ — Antithrombin Iii Quantitation
- Decision date
- 2025-03-28
- Date received
- 2024-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242952.pdf
Official FDA record: K242952
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.