Panther Fusion GI Expanded Bacterial Assay— 510(k) K251993
Substantially EquivalentHologic, Inc.
FDA 510(k) clearance K251993 for Panther Fusion GI Expanded Bacterial Assay, Substantially Equivalent on 2025-09-25. Applicant: Hologic, Inc.. Device class: 2.
Clearance details
- Applicant
- Hologic, Inc.
- Product code
- Code PCH
- Device class
- Class 2
- Regulation
- 21 CFR 866.3990
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code PCH
view allMore clearances from Hologic, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.