510(k) K252102 ยท MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Alinity m HCV
| Applicant | Abbott Molecular, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, Sep 25, 2025 |
| Received | Jul 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252102
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.