510(k) K013568 ยท DHX System, Test, Carcinoembryonic Antigen
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 21, 2001 |
| Received | Oct 26, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013568
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.