QUIDEL MOLECULAR RSV + HMPV ASSAY
FDA 510(k) clearance K122189 · decided 2013-03-08
Clearance details
- K-number
- K122189
- Device name
- QUIDEL MOLECULAR RSV + HMPV ASSAY
- Applicant
- Quidel Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-24
- Decision date
- 2013-03-08
- Days to decision
- 227 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Lyra RSV+hMPV Assay (K230349) | Quidel Corporation | 2023-03-10 |
| PRO HMPV+ ASSAY (K132200) | Gen-Probe Prodesse, Inc. | 2013-08-14 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| QUS-2 CALCANEAL ULTRASONOMETER (P990039/S001) | Quidel Corp. | 2003-06-19 |
| QUS-2 (TM) CALCANEAL ULTRASONOMETER (P990039) | Quidel Corp. | 2000-08-01 |