510(k) K895461 ยท GNB Antisera, All Types, Shigella Spp.
WELLCOLEX COLOUR SHIGELLA TEST ZC51
| Applicant | Wellcome Diagnostics, Research Triangle Pk NC, US |
| Decision | Substantially Equivalent, Jan 11, 1990 |
| Received | Sep 6, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895461
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.