510(k) K910697 ยท KLS Enzyme Immunoassay, Theophylline
IL THEOPHYLLINE ASSAY SYSTEM
| Applicant | Instrumentation Laboratory CO, Lexington MA, US |
| Decision | Substantially Equivalent, Apr 3, 1991 |
| Received | Feb 19, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910697
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.