PRO HMPV+ ASSAY
FDA 510(k) clearance K082688 · decided 2008-11-07
Clearance details
- K-number
- K082688
- Device name
- PRO HMPV+ ASSAY
- Applicant
- Prodesse, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-15
- Decision date
- 2008-11-07
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- OEM
- Device class
- 2
- Regulation number
- 866.3980
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Lyra RSV+hMPV Assay (K230349) | Quidel Corporation | 2023-03-10 |
| PRO HMPV+ ASSAY (K132200) | Gen-Probe Prodesse, Inc. | 2013-08-14 |
| QUIDEL MOLECULAR RSV + HMPV ASSAY (K122189) | Quidel Corp. | 2013-03-08 |
| PRO HMPV+ ASSAY (K123838) | Gen-Probe Prodesse, Inc. | 2013-01-16 |
| QUIDEL MOLECULAR HMPV ASSAY (K112490) | Quidel Corp. | 2011-12-15 |
Recalls involving this device
No recalls on record reference this clearance.