Cito CBC System— 510(k) K240402

Substantially Equivalent

Cytochip, Inc.

FDA 510(k) clearance K240402 for Cito CBC System, Substantially Equivalent on 2025-02-03. Applicant: Cytochip, Inc..

Clearance details

Applicant: Cytochip, Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2024-02-09
Decision date: 2025-02-03
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.