510(k) K240402

Cito CBC System by Cytochip, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2025
Date Received
February 9, 2024
Clearance Type
Dual Track
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type