510(k) K202215 ยท QMI Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Sep 2, 2020 |
| Received | Aug 6, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202215
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.