510(k) K232286 ยท PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
| Applicant | Quidel Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 20, 2023 |
| Received | Aug 1, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232286
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.