510(k) K843826 ยท LGS Fluorescence Polarization Immunoassay, Theophylline
COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL
| Applicant | Roche Diagnostic Systems, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Feb 1, 1985 |
| Received | Sep 28, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843826
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.