K241220
- 510(k) number
- K241220
- Device name
- Tina-quant Lipoprotein(a) Gen.2 Molarity
- Applicant
- Roche Diagnostics Operations IN · US
- Product code
- DFC — Lipoprotein, Low-Density, Antigen, Antiserum, Contro
- Decision date
- 2025-01-24
- Date received
- 2024-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K241220.pdf
Official FDA record: K241220
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.