510(k) K003400 ยท DCN System, Test, C-Reactive Protein
CRP HS TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 10, 2001 |
| Received | Nov 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003400
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.