510(k) K252484 ยท MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
cobas HCV
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Nov 3, 2025 |
| Received | Aug 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252484
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.