510(k) K243489 ยท QLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
Alinity m EBV (09N43-095)
| Applicant | Abbott Molecular, Inc., Des Plaines IL, US |
| Decision | Substantially Equivalent, Jul 28, 2025 |
| Received | Nov 12, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243489
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.