510(k) K993028 ยท KLT Enzyme Immunoassay, Carbamazepine
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90
| 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 K993028
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.