510(k) K233352 ยท MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Aptima HCV Quant Dx Assay
| Applicant | Hologic, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 24, 2024 |
| Received | Sep 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233352
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.