510(k) K900009 ยท KLS Enzyme Immunoassay, Theophylline
NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
| Applicant | Kallestad Diag, A Div. of Erbamont, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Mar 29, 1990 |
| Received | Jan 2, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900009
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.