510(k) K082140 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
XPERT MRSA/SA BLOOD CULTURE ASSAY
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 29, 2008 |
| Received | Jul 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082140
| 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 |
| Jul 1, 2010 | Cepheid Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA.
Medical device, qualitative in vitro diagnostic test intended for the detection Terminated |
NQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.