510(k) K871329 ยท LCD Enzyme Immunoassay, Gentamicin
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
| Applicant | Em Diagnostic Systems, Inc., Gibbstown NJ, US |
| Decision | Substantially Equivalent, May 12, 1987 |
| Received | Apr 3, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871329
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.