510(k) K904393 ยท MDU Antigen, Elisa, Cryptococcus
PREMIER-CRYPTOCOCCAL ANTIGEN
| Applicant | Meridian Diagnostics, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jan 25, 1991 |
| Received | Sep 25, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2018 | Meridian Bioscience Inc PREMIER Cryptococcal Antigen, Catalog Number 602096
Product Usage:
The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of ca Terminated |
MDU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.