510(k) K801642 ยท KLS Enzyme Immunoassay, Theophylline
FIAX TEST KIT FOR THEOPHYLLINE QUANT.
| Applicant | Intl. Diagnostic Technology, Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 27, 1980 |
| Received | Jul 17, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801642
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.