510(k) K812003 ยท KLS Enzyme Immunoassay, Theophylline
A-GENT THEOPHYLLINE
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Jul 27, 1981 |
| Received | Jul 14, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812003
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.