510(k) K932685 ยท KLS Enzyme Immunoassay, Theophylline
PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
| Applicant | Baxter Diagnostics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 24, 1993 |
| Received | Jun 3, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932685
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.