Changchun LYZ Technology Co.,LTD

FDA Device Registration & Listing · Changchun City Jilin, CN · Registration 3024171133

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3024171133
FEI Number
3024171133
Entity Name
Changchun LYZ Technology Co.,LTD
City/State/Country
Changchun City Jilin, CN
Establishment Address
Room 601.602, 6th Floor, Plant 3#, Construction Project of Sealed molding Products, 899 Yueda Road, High-tech Development Zone, Changchun City Jilin 130102, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Changchun LYZ Technology Co.,LTD (Owner Number: 10087523)
Owner / Operator Contact Address
Room 601.602, 6th Floor, Plant 3#, Construction Project of Sealed molding Products, 899 Yueda Road, High-tech Development Zone, Changchun City, CN-JL 130102, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NITRITE, Urine Test Strips, UTI Test Strips PROTEIN, Urine Test Strips, MICROALBUMIN, Urine Test Strips VAGINAL pH Test Strips UROBILINOGEN, Urine Test Strips LEUKOCYTES, Urine Test Strips, UTI Test Strips KETONE, Urine Test Strips SG, SPECIFIC GRAVITY, Urine Test Strips Lead Test Swabs Food Test Strips, Pesticide Residue Test Cards, Water Test Machine, Blood Glucose Meter, Blood Pressure Meter, Oximeter, Nebulizer, Thermometer, Varicose Socks), Soil Nitrogen Test Strips, Soil Phosphorus Test Strips, EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE (Oil Test Strips, Soil Potassium Test Strips FSH Rapid test Kits Pet Test Strips pH, Urine Test Strips, UTI Test Strips Chlorine test strips Water Test Strips, Hardness Test Strips, Pool Test Strips, Aquarium Test Strips, Drinking Water Test Strips,

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2023-03-10
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2023-03-10
LNW Paper, Obstetric Ph Clinical Chemistry Class 1 862.1550 2023-03-10
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2024-10-22
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2023-03-10
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2023-03-10
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2024-10-22
JXA Kit, Screening, Urine Microbiology Class 1 866.2660 2024-10-22
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2023-03-10
NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter Clinical Chemistry Class 1 862.1300 2024-10-25
JIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2023-03-10
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2024-10-22
JTO Discs, Strips And Reagents, Microorganism Differentiation Microbiology Class 1 866.2660 2024-10-25

Official Correspondent

Paul Liu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Changchun LYZ Technology Co.,LTD
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
K885053 Biotrol, USA, Inc. BIOTROL URINE PROTEINS REAGENT 1989-01-30
K770926 Analytical Products, Inc. SUSPENSION SALINE, API 20E 1977-06-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-04 Instrumentation Laboratory Co. 1
Lactate Disposable Membrane Caps Product Number: 0018108400
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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1417592 MEDLINE INDUSTRIES, LP - Northfield Northfield, IL, US
3013077867 SAFECARE BIOTECH(HANGZHOU)CO.,LTD Huzhou Zhejiang, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024171133. Last updated year: 2026. Please use registration number 3024171133 when referencing this establishment in official correspondence.
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