510(k) K101879 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 28, 2010 |
| Received | Jul 6, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101879
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Cepheid Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001; Terminated |
NQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.