510(k) K962519 ยท LCD Enzyme Immunoassay, Gentamicin
EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
| Applicant | Behring Diagnostics, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Sep 4, 1996 |
| Received | Jun 27, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962519
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.