Medical Device Manufacturer · US , San Diego , CA

Hologic / Gen-Probe Incorporated - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2013

Recent clearances: APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)

View 1 510(k) Devices ↓

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hologic / Gen-Probe Incorporated Microbiology ✕

1 devices

1-1 of 1

Cleared CT Oct 17, 2013

APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)

Microbiology · 90d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Sep 19, 2026