510(k) K122722 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 29, 2012 |
| Received | Sep 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122722
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.