510(k) K850629 ยท LGS Fluorescence Polarization Immunoassay, Theophylline
INNOFLUOR THEOPHYLLINE
| Applicant | Innotron Diagnostics, Irvine CA, US |
| Decision | Substantially Equivalent, Mar 12, 1985 |
| Received | Feb 19, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850629
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.