510(k) K241921 ยท QMI Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
Alinity m BKV
| Applicant | Abbott Molecular, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, Mar 24, 2025 |
| Received | Jul 1, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241921
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.