510(k) K040241 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Jun 25, 2004 |
| Received | Feb 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040241
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.