510(k) K012311 ยท LCD Enzyme Immunoassay, Gentamicin
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Aug 20, 2001 |
| Received | Jul 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012311
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.