510(k) K163626 ยท OZZ Bordetella Pertussis Dna Assay System
ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
| Applicant | Luminex Corporation, Austin TX, US |
| Decision | Substantially Equivalent, May 2, 2017 |
| Received | Dec 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163626
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2019 | Luminex Corporation Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452 Open, Classified |
OZZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.