DEVICE CLASS
Class II
REGULATION
21 CFR 864.5220
MEDICAL SPECIALTY
Hematology
REVIEW PANEL
HE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES
Recent clearances
K253212Sysmex America, Inc. · 510k2026-05-27
K243348Athelas, Inc. · 510k2026-02-06
K251249Truvian Sciences, Inc. · 510k2026-01-16
K250943Sysmex America, Inc. · 510k2025-06-25
K251371Sysmex America, Inc. · 510k2025-06-25
K243283Abbott Laboratories · 510k2025-02-20
K240402Cytochip, Inc. · 510k2025-02-03
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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