510(k) K002651 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Oct 13, 2000 |
| Received | Aug 25, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002651
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.