510(k) K180559 ยท PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
| Applicant | Elitechgroup, Bothell WA, US |
| Decision | Substantially Equivalent, Oct 29, 2018 |
| Received | Mar 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180559
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.