510(k) K190771 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 25, 2019 |
| Received | Mar 26, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190771
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.