510(k) K050755 ยท MXB Test, Vaginal, Bacterial Sialidase
MODIFICATION TO BVBLUE
| Applicant | Gryphus Diagnostics, LLC, Rockville MD, US |
| Decision | Substantially Equivalent, Apr 6, 2005 |
| Received | Mar 23, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050755
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Sekisui Diagnostics Control Kit OSOM BVBLUE Bacterial Vaginosis Open, Classified |
MXB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.