510(k) K233349 ยท PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Alinity m HSV 1 & 2 / VZV
| Applicant | Abbott Molecular, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, May 3, 2024 |
| Received | Sep 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233349
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.