FDA 510(k) Applications for Medical Device Product Code "OEM"
(Human Metapneumovirus (Hmpv) Rna Assay System)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K132200 | GEN-PROBE PRODESSE, INC | PRO HMPV+ ASSAY | 08/14/2013 |
| K123838 | GEN-PROBE PRODESSE, INC. | PRO HMPV+ ASSAY | 01/16/2013 |
| K082688 | PRODESSE, INC. | PRO HMPV+ ASSAY | 11/07/2008 |
| K112490 | QUIDEL CORP. | QUIDEL MOLECULAR HMPV ASSAY | 12/15/2011 |
| K122189 | QUIDEL CORP. | QUIDEL MOLECULAR RSV + HMPV ASSAY | 03/08/2013 |
| K230349 | Quidel Corporation | Lyra RSV+hMPV Assay | 03/10/2023 |
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