Panther Fusion AdV/hMPV/RV Assay— 510(k) K231017
Substantially EquivalentHologic, Inc.
FDA 510(k) clearance K231017 for Panther Fusion AdV/hMPV/RV Assay, Substantially Equivalent on 2023-05-05. Applicant: Hologic, Inc.. Device class: 2.
Clearance details
- Applicant
- Hologic, Inc.
- Product code
- Code OCC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
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More clearances from Hologic, Inc.
view allAdverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.