510(k) K943979 ยท KLS Enzyme Immunoassay, Theophylline
IL TEST THEOPHYLLINE
| Applicant | Instrumentation Laboratory CO, Lexington MA, US |
| Decision | Substantially Equivalent, Jan 18, 1995 |
| Received | Jun 7, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943979
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.