510(k) K862350 ยท KLS Enzyme Immunoassay, Theophylline
EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Jul 7, 1986 |
| Received | Jun 20, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862350
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.