510(k) K812518 ยท LER Fluorescent Immunoassay, Theophylline
AMES TDA THEOPHYLLINE TEST
| Applicant | Miles Laboratories, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Sep 23, 1981 |
| Received | Sep 2, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812518
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.