510(k) K020740 ยท KLS Enzyme Immunoassay, Theophylline
ROCHE ONLINE THEOPHYLLINE
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 16, 2002 |
| Received | Mar 6, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020740
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.