510(k) K864041 ยท KLS Enzyme Immunoassay, Theophylline
EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, Nov 25, 1986 |
| Received | Oct 16, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864041
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.