510(k) K181333 · MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
ADVIA Centaur Herpes-1 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 K181333
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.