510(k) K873596 ยท KLS Enzyme Immunoassay, Theophylline
BAKER TDM THEOPHYLLINE ASSAY
| Applicant | Baker Instructions Corp., Winchester VA, US |
| Decision | Substantially Equivalent, Oct 20, 1987 |
| Received | Sep 4, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K873596
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.