510(k) K221007 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 4, 2022 |
| Received | Apr 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221007
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.