510(k) K884358 ยท KLS Enzyme Immunoassay, Theophylline
CEDIA THEOPHYLLINE ASSAY
| Applicant | Microgenics Corp., Concord CA, US |
| Decision | Substantially Equivalent, Feb 7, 1989 |
| Received | Oct 17, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884358
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.