Panther Fusion Paraflu Assay
FDA 510(k) clearance K172282 · decided 2017-10-23
Clearance details
- K-number
- K172282
- Device name
- Panther Fusion Paraflu Assay
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-07-28
- Decision date
- 2017-10-23
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- OOU
- 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 |
|---|---|---|
| ProParaFlu+ Assay (K153223) | Hologic, Inc. | 2015-12-09 |
| LYRA PARAINFLUENZA VIRUS ASSAY (K141927) | Quidel Corporation | 2014-10-09 |
| PROPARAFLU+ ASSAY (K132238) | Gen-Probe Prodesse, Inc. | 2013-08-26 |
| PROPARAFLU+ASSAY (K091053) | Prodesse, Inc. | 2009-11-20 |
Recalls involving this device
No recalls on record reference this clearance.
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