510(k) K013272 ยท KLS Enzyme Immunoassay, Theophylline
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Oct 25, 2001 |
| Received | Oct 1, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013272
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.