Panther Fusion GI Expanded Bacterial Assay
FDA 510(k) clearance K251993 · decided 2025-09-25
Clearance details
- K-number
- K251993
- Device name
- Panther Fusion GI Expanded Bacterial Assay
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-27
- Decision date
- 2025-09-25
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- PCH
- Device class
- 2
- Regulation number
- 866.3990
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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| Aptima HBV Quant Assay (P170025/S022) | Hologic, Inc. | 2024-10-23 |