510(k) K181334 · MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
ADVIA Centaur Herpes-2 IgG
| Applicant | Biokit, S.A., Lliça D'Amunt, ES |
| Decision | Substantially Equivalent, Aug 23, 2018 |
| Received | May 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181334
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2021 | Siemens Healthcare Diagnostics, Inc Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 Terminated |
MYF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.