510(k) K811617 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.
| Applicant | Kallestad Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 25, 1981 |
| Received | Jun 8, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811617
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.