510(k) K241220 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Tina-quant Lipoprotein(a) Gen.2 Molarity
| Applicant | Roche Diagnostics Operations, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 24, 2025 |
| Received | May 1, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241220
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.