510(k) K854183 ยท KLS Enzyme Immunoassay, Theophylline
IN VITRO TEST DETERMINATION OF THEOPHYLLINE
| Applicant | Clinical Data, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Dec 19, 1985 |
| Received | Oct 15, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854183
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.