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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K240402
Device Name Cito CBC System
Applicant
CytoChip Inc.
18 Technology Dr, Suite 200
Irvine,  CA  92618
Applicant Contact Wendian Shi
Correspondent
CytoChip Inc.
18 Technology Dr, Suite 200
Irvine,  CA  92618
Correspondent Contact Wendian Shi
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/09/2024
Decision Date 02/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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