Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014060475

FEI Number

3014060475

Entity Name

Zenith Lab (Jiangsu) Co.,LTD

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No.12 Hongshan Road Jincheng Industry Area, Jintan District, Changzhou Jiangsu 213200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AIKEN CORP. (Owner Number: 10056010)

Owner / Operator Contact Address

1979W HOLT AVE, Pomona, CA 91768, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CENTRIFUGE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic Use	Hematology	Class 1	864.9275	2018-07-25

Official Correspondent

XIANGFANG YANG

US Agent Details

XIFANG YANG Business: AIKEN CORP Email: info@aikencorp.com Phone: (909) 8681800

Related Public Records

Same Entity

AIKEN CORP.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014060475. Last updated year: 2026. Please use registration number 3014060475 when referencing this establishment in official correspondence.