510(k) K901510 ยท KLS Enzyme Immunoassay, Theophylline
ENZYMATIC THEOPHYLLINE REAGENT, #500-82
| Applicant | Diagnostic Chemicals, Ltd. (Usa), Oxford CT, US |
| Decision | Substantially Equivalent, Jun 12, 1990 |
| Received | Mar 30, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901510
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.