Hologic, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Panther Fusion GI Expanded Bacterial Assay, Genius AI Detection 2.0, Aptima SARS-CoV-2 Assay
115
Total
111
Cleared
2
Denied
FDA 510(k) Regulatory Record - Hologic, Inc. Pathology ✕
5 devices
Not Cleared
Jan 31, 2024
“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”
Pathology
887d
Cleared
Jun 02, 2011
INVADER FACTOR II
Pathology
422d
Cleared
Jun 01, 2011
INVADER FACTOR V
Pathology
419d
Cleared
May 13, 2011
INVADER MTHFR 677
Pathology
399d
Cleared
Apr 25, 2011
INVADER MTHFR 1298
Pathology
427d