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FDA 510(k)

Cito CBC System

K-Number: K240402 · 2025-02-03

ApplicantCytochip, Inc.
Decision Date2025-02-03
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Cito CBC System is the device name listed in this FDA 510(k) record. The listed applicant is Cytochip, Inc.. It received FDA 510(k) clearance on 2025-02-03 under 510(k) number K240402. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cito CBC System?

Cito CBC System is a medical device that received FDA 510(k) clearance on 2025-02-03. The listed applicant is Cytochip, Inc.. The 510(k) number is K240402.

When did Cito CBC System receive FDA 510(k) clearance?

Cito CBC System received FDA 510(k) clearance on 2025-02-03, under 510(k) number K240402.

Who is the listed applicant for Cito CBC System?

The FDA 510(k) record lists Cytochip, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cito CBC System?

The FDA product code for Cito CBC System is GKZ.

Related Devices (Code: GKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K243283Alinity h-series SystemAbbott Laboratories

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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