510(k) K142721 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
cobas MRSA/SA Test
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Dec 17, 2014 |
| Received | Sep 23, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142721
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2017 | Roche Molecular Systems, Inc. Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic. Terminated |
NQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.