510(k) K161495 ยท OOI Real Time Nucleic Acid Amplification System
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
| Applicant | Luminex Corporation, Austin TX, US |
| Decision | Substantially Equivalent, Jun 30, 2016 |
| Received | Jun 1, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161495
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2021 | Luminex Corporation ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 Terminated |
OOI | None listed |
| Apr 16, 2021 | Luminex Corporation ARIES HSV 1&2 Assay, Part Number/REF 50-10017 Terminated |
OOI | None listed |
| Aug 19, 2019 | Luminex Corporation Luminex Aries M1 System
Model: Aries M6V1
Aries Software v1.0
For In Vitro Diagnostic Use in clinical laboratories.
Scanner Label/Labeling:
JADAK
JDK-2330 REV B 170512-017 Terminated |
OOI | None listed |
| 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.