Cleared Dual Track

Cito CBC System

K240402 · Cytochip, Inc. · Hematology

Feb 2025

Decision

360d

Days

Class 2

Risk

About This 510(k) Submission

K240402 is an FDA 510(k) clearance for the Cito CBC System, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Cytochip, Inc. (Irvine, US). The FDA issued a Cleared decision on February 3, 2025, 360 days after receiving the submission on February 9, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K240402 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 2024
Decision Date	February 03, 2025
Days to Decision	360 days
Submission Type	Dual Track
Review Panel	Hematology (HE)
Summary	Summary PDF