510(k) K940376 ยท LCD Enzyme Immunoassay, Gentamicin
QMS GENTAMICIN ASSAY
| Applicant | Seradyn, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 2, 1994 |
| Received | Jan 26, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940376
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.