510(k) K991385 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
DADE BEHRING N HIGH SENSITIVITY CRP ASSAY
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Oct 25, 1999 |
| Received | Apr 21, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991385
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.