510(k) K042407 ยท KLS Enzyme Immunoassay, Theophylline
EMIT CAFFEINE ASSAY
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Oct 28, 2004 |
| Received | Sep 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042407
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.