FDA 510(k) Pathology Devices

FDA 510(k) Pathology Devices - Regulatory Overview

FDA 510(k) pathology devices include instruments used in anatomical and clinical pathology laboratories. The FDA review panel code is PA.

Key categories:

• Tissue staining systems - automated H&E, IHC and special stain platforms
• Histology instruments - microtomes, tissue processors and embedding stations
• Digital pathology - whole slide imaging (WSI) scanners and image analysis software
• Cytology systems - liquid-based cytology and automated cell screening

Most pathology devices are Class I or Class II under 21 CFR Part 864. Data sourced from FDA 510(k) public files. Updated monthly.