510(k) K853858 ยท KLS Enzyme Immunoassay, Theophylline
IL TEST THEOPHYLLINE ASSAY
| Applicant | Allied Instrumentation Laboratory, Lexington MA, US |
| Decision | Substantially Equivalent, Oct 15, 1985 |
| Received | Sep 16, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853858
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.