510(k) K800646 ยท KLS Enzyme Immunoassay, Theophylline
AMES TDA THEOPHYL-LINE TEST
| Applicant | Miles Laboratories, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Apr 10, 1980 |
| Received | Mar 24, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800646
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.