Panther Fusion AdV/hMPV/RV Assay— 510(k) K172629

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K172629 for Panther Fusion AdV/hMPV/RV Assay, Substantially Equivalent on 2017-12-04. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2017-09-01
Decision date: 2017-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.