510(k) K885001 ยท DCN System, Test, C-Reactive Protein
QM300 PCR ANTIBODY PACK
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Dec 20, 1988 |
| Received | Dec 1, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885001
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.