510(k) DEN200015 ยท QLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Unknown, Jul 30, 2020 |
| Received | Mar 2, 2020 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN200015
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.