Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034731501

FEI Number

3034731501

Entity Name

Kunming Lianen Biotechnology Co., LTD

City/State/Country

Kunming Yunnan, CN

Establishment Address

3rd Floor, Building 3, No. 1676 Gaodeng Street, Majinpu, Kunming Yunnan 650503, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Kunming Lianen Biotechnology Co., LTD (Owner Number: 10092182)

Owner / Operator Contact Address

3rd Floor, Building 3, No. 1676 Gaodeng Street, Majinpu, Kunming, CN-YN 650503, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LOOKEE® AscleTrack Urine Test Analyzer, model A80 LOOKEE® AscleTrack Urine Microalbumin (MAU) Test Strip, model A802

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2025-03-27
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2026-05-29

Official Correspondent

Frank Deng

US Agent Details

Simin Lin Email: simin_lin123@126.com Phone: (415) 6026843

Related Public Records

Same Entity

Kunming Lianen Biotechnology 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
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23
K885053	Biotrol, USA, Inc.	BIOTROL URINE PROTEINS REAGENT	1989-01-30

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3008517993	ZHEJIANG ORIENT GENE BIOTECH	Huzhou Zhejiang, CN
3005360469	ACRO BIOTECH Inc.	Montclair, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034731501. Last updated year: 2026. Please use registration number 3034731501 when referencing this establishment in official correspondence.