PROPARAFLU+ ASSAY
FDA 510(k) clearance K132238 · decided 2013-08-26
Clearance details
- K-number
- K132238
- Device name
- PROPARAFLU+ ASSAY
- Applicant
- Gen-Probe Prodesse, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-18
- Decision date
- 2013-08-26
- Days to decision
- 39 days
- Clearance type
- Special
- Product code
- OOU
- 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 |
|---|---|---|
| Panther Fusion Paraflu Assay (K172282) | Hologic, Inc. | 2017-10-23 |
| ProParaFlu+ Assay (K153223) | Hologic, Inc. | 2015-12-09 |
| LYRA PARAINFLUENZA VIRUS ASSAY (K141927) | Quidel Corporation | 2014-10-09 |
| PROPARAFLU+ASSAY (K091053) | Prodesse, Inc. | 2009-11-20 |
Recalls involving this device
No recalls on record reference this clearance.