510(k) K905521 ยท LER Fluorescent Immunoassay, Theophylline
CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION
| Applicant | Microgenics Corp., Concord CA, US |
| Decision | Substantially Equivalent, Dec 26, 1990 |
| Received | Dec 7, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905521
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.