510(k) K203220 ยท QLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
cobas BKV
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Jan 29, 2021 |
| Received | Nov 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203220
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.