510(k) K082688
- Device
- PRO HMPV+ ASSAY
- Applicant
- PRODESSE, INC.
- 510(k) number
- K082688
- Product code
- OEM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-11-07
- Date received
- 2008-09-15
- Regulation
- 866.3980
- Classification name
- Human Metapneumovirus (hmpv) Rna Assay System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN HARRINGTON
- Address
- W229n1870 Westwood Dr. Waukesha WI US 53186 53186
FDA Registration Numbers#
- 3013019728
- 3003030793
- 2024800
- 3010770794
- 1221359
- 3002777243
- 3007799234
- 3006028115
- 3019946577
- 3038610665
- 1650733
- 3006198300
- 3002773840
- 1528450
- 3008632402
Source Documents#
Other 510(k) Records For Product Code OEM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230349 | Lyra RSV+hMPV Assay | Quidel Corporation | 2023-03-10 |
| K132200 | PRO HMPV+ ASSAY | Gen-Probe Prodesse, Inc. | 2013-08-14 |
| K122189 | QUIDEL MOLECULAR RSV + HMPV ASSAY | Quidel Corp. | 2013-03-08 |
| K123838 | PRO HMPV+ ASSAY | Gen-Probe Prodesse, Inc. | 2013-01-16 |
| K112490 | QUIDEL MOLECULAR HMPV ASSAY | Quidel Corp. | 2011-12-15 |
Legacy Summary#
summary
FDA Review#
Decision Summary