510(k) K181443 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Accula RSV Test
| Applicant | Mesa Biotech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 23, 2018 |
| Received | May 31, 2018 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K181443
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.