Panther Fusion GBS Assay
FDA 510(k) clearance K181156 · decided 2018-07-27
Clearance details
- K-number
- K181156
- Device name
- Panther Fusion GBS Assay
- Applicant
- Diagenode
- Decision
- Substantially Equivalent
- Date received
- 2018-05-01
- Decision date
- 2018-07-27
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- NJR
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Seraing, BE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge recall (Z-0907-2025) | Hologic, Inc. | 2025-01-14 |
| Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnost recall (Z-0877-2022) | Hologic, Inc | 2022-04-06 |