The following data is part of a premarket notification filed by Quidel Corp. with the FDA for Quidel Molecular Rsv + Hmpv Assay.
| Device ID | K122189 |
| 510k Number | K122189 |
| Device Name: | QUIDEL MOLECULAR RSV + HMPV ASSAY |
| Classification | Human Metapneumovirus (hmpv) Rna Assay System |
| Applicant | QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Contact | Ronald H Lollar |
| Correspondent | Ronald H Lollar QUIDEL CORP. 10165 MCKELLAR CT. San Diego, CA 92121 |
| Product Code | OEM |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-24 |
| Decision Date | 2013-03-08 |
| Summary: | summary |