510(k) K840758 ยท LER Fluorescent Immunoassay, Theophylline
IMMPULSE THEOPHYLLINE ASSAY REAGENTS
| Applicant | Paragon Diagnostics, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Apr 4, 1984 |
| Received | Feb 23, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840758
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.