510(k) K012337 ยท DCN System, Test, C-Reactive Protein
BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 6, 2001 |
| Received | Jul 24, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012337
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.