510(k) K162772 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
ARIES GBS Assay
| Applicant | Luminex Corporation, Austin TX, US |
| Decision | Substantially Equivalent, Dec 23, 2016 |
| Received | Oct 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162772
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 GBS Assay , REF 50-10021, UDI # 00840487100165 Open, Classified |
NJR | None listed |
| Apr 19, 2017 | Luminex Corporation ARIES System and ARIES M1 System Terminated |
OOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.