510(k) K972495 ยท KLS Enzyme Immunoassay, Theophylline
ACCUMETER THEOPHYLLINE TEST
| Applicant | Chemtrak, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 10, 1997 |
| Received | Jul 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972495
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.