510(k) K893753 ยท LHK Antigen, Id, Candida Albicans
DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Oct 16, 1989 |
| Received | May 19, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893753
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.