510(k) K823576 ยท LER Fluorescent Immunoassay, Theophylline
COBAS STANDARD FOR TOTAL PROTEIN
| Applicant | Hoffmann-La Roche, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jan 7, 1983 |
| Received | Dec 6, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K823576
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.