510(k) K832825 ยท KLS Enzyme Immunoassay, Theophylline
SERALYZER THEOPHYLLINE REAGENT STRIPS
| Applicant | Miles Laboratories, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Mar 19, 1984 |
| Received | Aug 19, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K832825
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.