Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038625004

FEI Number

3038625004

Entity Name

ONECHIPDX BIOTECH (SUZHOU) CO., LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Unit 302, A6 Bldg, Phase I Biomedical Industrial Park, No.218 Xinghu Str, Suzhou Industrial Park, Suzhou Jiangsu 215028, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

CytoChip Inc. (Owner Number: 10093532)

Owner / Operator Contact Address

18 Technology Dr, Suite 200, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CitoCBC System CitoCBC Control

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2025-05-29
JCN	Control, Cell Counter, Normal And Abnormal	Hematology	Class 2	864.8625	2025-09-02

Official Correspondent

Wendian Shi

US Agent Details

Wendian Shi Business: CytoChip Inc. Email: wendian@cytochipinc.com Phone: (949) 5226668

Related Public Records

Same Entity

CytoChip Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0011-2014	Siemens Healthcare Diagnostics	2	ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013	Beckman Coulter Inc.	2	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Z-0033-2013	Beckman Coulter Inc.	2	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

Similar Registrations

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2182501	R & D SYSTEMS, INC.	MINNEAPOLIS, MN, US
9613959	SYSMEX CORPORATION TECHNO PARK	KOBE Hyogo, JP
3002759288	SYSMEX CORPORATION KAKOGAWA FACTORY	Kakogawa Hyogo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038625004. Last updated year: 2026. Please use registration number 3038625004 when referencing this establishment in official correspondence.