510(k) K040434 ยท DEW Igg, Antigen, Antiserum, Control
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 10, 2004 |
| Received | Feb 19, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040434
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.