The following data is part of a premarket notification filed by Prodesse, Inc. with the FDA for Pro Hmpv+ Assay.
| Device ID | K082688 |
| 510k Number | K082688 |
| Device Name: | PRO HMPV+ ASSAY |
| Classification | Human Metapneumovirus (hmpv) Rna Assay System |
| Applicant | PRODESSE, INC. W229 N1870 WESTWOOD DR. Waukesha, WI 53186 |
| Contact | Karen Harrington |
| Correspondent | Karen Harrington PRODESSE, INC. W229 N1870 WESTWOOD DR. Waukesha, WI 53186 |
| Product Code | OEM |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-15 |
| Decision Date | 2008-11-07 |
| Summary: | summary |