510(k) K132822 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
BD MAX STAPHSR ASSAY, INSTRUMENT
| Applicant | Geneohm Sciences Canada, Inc. (Bd Diagnostics), Quebec, CA |
| Decision | Substantially Equivalent, Nov 26, 2013 |
| Received | Sep 9, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132822
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max StaphSR;
Catalog # 443418 Terminated |
NQX | None listed |
| Jul 17, 2019 | Becton Dickinson & Co. Kit BD Max StaphSR;
Catalog # 443419 Terminated |
NQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.