510(k) K982087 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
ROCHE CRP T CONTROL N
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Aug 18, 1998 |
| Received | Jun 15, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982087
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.