510(k) K993029 ยท KLS Enzyme Immunoassay, Theophylline
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89
| Applicant | Syva Co., San Jose CA, US |
| Decision | Substantially Equivalent, Jan 27, 2000 |
| Received | Sep 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993029
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.