510(k) DEN240016 ยท SBP Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
Xpert HCV; GeneXpert Xpress System
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Unknown, Jun 27, 2024 |
| Received | Apr 16, 2024 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN240016
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.