FDA 510(k) Hematology Devices

FDA 510(k) Hematology Devices - Regulatory Overview

FDA 510(k) hematology devices include automated instruments used to analyze blood composition and coagulation. The FDA review panel code is HE.

Key device categories:

• Complete blood count (CBC) analyzers - automated cell counters for RBC, WBC and platelets
• Coagulation analyzers - PT/INR, aPTT, fibrinogen and factor assays
• Flow cytometry systems - immunophenotyping and cell sorting
• Blood typing and cross-match systems - transfusion medicine instruments

Most hematology devices are classified as Class II under 21 CFR Part 864. Data sourced from FDA 510(k) public files. Updated monthly.