510(k) DEN130032 ยท PEU System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
XPERT MTB/RIF ASSAY
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Unknown, Jul 25, 2013 |
| Received | Jun 11, 2013 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN130032
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.