510(k) K183597 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
QIAstat-Dx Respiratory Panel
| Applicant | QIAGEN GmbH, Hilden, DE |
| Decision | Substantially Equivalent, May 18, 2019 |
| Received | Dec 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183597
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.