510(k) K012301 ยท KXT Enzyme Immunoassay, Digoxin
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Sep 19, 2001 |
| Received | Jul 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012301
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.