510(k) K951631 ยท LFM Enzyme Immunoassay, Digitoxin
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
| Applicant | Bayer Corp., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jun 9, 1995 |
| Received | Apr 7, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951631
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.