510(k) K151906 ยท PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
| Applicant | Luminex Corporation, Austin TX, US |
| Decision | Substantially Equivalent, Oct 6, 2015 |
| Received | Jul 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151906
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2019 | Luminex Corporation ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295 Open, Classified |
PGI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.