510(k) K071026 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
BD GENEOHM STAPHSR ASSAY
| Applicant | Bd Diagnostics (Geneohm Sciences Canada, Inc), San Diego CA, US |
| Decision | Substantially Equivalent, Dec 20, 2007 |
| Received | Apr 11, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071026
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.