510(k) K801476 ยท KLS Enzyme Immunoassay, Theophylline
APPLICATION OF EMIT THEOPHYLLINE ASSAY
| Applicant | Syva Co., Walker MI, US |
| Decision | Substantially Equivalent, Jul 8, 1980 |
| Received | Jun 24, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801476
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.