510(k) K173798 ยท PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
| Applicant | Diasorin Molecular, LLC, Cypress CA, US |
| Decision | Substantially Equivalent, Mar 14, 2018 |
| Received | Dec 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173798
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.