510(k) K171441 ยท OZN C. Difficile Toxin Gene Amplification Assay
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
| Applicant | Luminex Corporation, Austin TX, US |
| Decision | Substantially Equivalent, Jul 21, 2017 |
| Received | May 16, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171441
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2019 | Luminex Corporation ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059 Open, Classified |
OZN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.