510(k) K093346 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
BD GENEOHM MRSA ACP ASSAY
| Applicant | Bd Diagnostics (Geneohm Sciences, Inc.), San Diego CA, US |
| Decision | Substantially Equivalent, Dec 15, 2009 |
| Received | Oct 26, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093346
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2012 | Becton Dickinson & Co. BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***
BD GeneOhm MRSA ACP Assay is a Terminated |
LLH | None listed |
| Sep 6, 2012 | Becton Dickinson & Co. BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***
BD GeneOhm MRSA ACP Assay is Terminated |
NQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.