510(k) K953020 ยท LCD Enzyme Immunoassay, Gentamicin
ACS GENTAMICIN
| Applicant | Ciba Corning Diagnostics Corp., East Walpole MA, US |
| Decision | Substantially Equivalent, Aug 2, 1995 |
| Received | Jun 29, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953020
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.