510(k) K243575 · MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
| Applicant | Biokit, S.A., Lliçà DAmunt, Barcelona, ES |
| Decision | Substantially Equivalent, Feb 12, 2025 |
| Received | Nov 19, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243575
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.