510(k) K163628 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Idylla Respiratory (IFV-RSV) Panel
| Applicant | Janssen Pharmaceutica NV, Beerse, BE |
| Decision | Substantially Equivalent, Aug 30, 2017 |
| Received | Dec 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163628
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.