510(k) K172402 ยท PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
| Applicant | Luminex Corporation, Austin TX, US |
| Decision | Substantially Equivalent, Oct 30, 2017 |
| Received | Aug 9, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172402
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2019 | Luminex Corporation ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469 Open, Classified |
PGX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.