Lyra RSV+hMPV Assay
FDA 510(k) clearance K230349 · decided 2023-03-10
Clearance details
- K-number
- K230349
- Device name
- Lyra RSV+hMPV Assay
- Applicant
- Quidel Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-02-09
- Decision date
- 2023-03-10
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- OEM
- Device class
- 2
- Regulation number
- 866.3980
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, 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 |
|---|---|---|
| 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 |
| PRO HMPV+ ASSAY (K082688) | Prodesse, Inc. | 2008-11-07 |
Recalls involving this device
No recalls on record reference this clearance.