510(k) K911060 ยท KLS Enzyme Immunoassay, Theophylline
IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM
| Applicant | Immunomatrix, Potomac MD, US |
| Decision | Substantially Equivalent, May 8, 1991 |
| Received | Mar 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911060
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.