510(k) K213987 · MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
| Applicant | Biokit, S.A., Lliçà D´Amunt, ES |
| Decision | Substantially Equivalent, Sep 20, 2023 |
| Received | Dec 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213987
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.