Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023197868

FEI Number

3023197868

Entity Name

TST BIOMEDICAL ELECTRONICS CO., LTD.

City/State/Country

Taoyuan, TW

Establishment Address

2F, No. 3, Industrial 2nd Rd., Pingzhen Dis., Taoyuan City, Taiwan, Taoyuan 324, TW

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

tst Biomedical Electronics Co., Ltd. (Owner Number: 10087980)

Owner / Operator Contact Address

2F, No. 3, Industrial 2nd Rd., Pingzhen Dis., Taoyuan City, Taiwan, Taoyuan, TW-TAO 324, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iPro-Lab HDL Cholesterol Kit iPro-Lab Lipid Panel iProtin ApoA1 Assay Cartridge Kit iProtin ApoB Assay Cartridge Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2023-07-20
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2023-07-20
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2023-05-26

Official Correspondent

No official correspondent registered.

US Agent Details

Feng-Yu Lee Email: fengyulee@ivddreg.com Phone: (949) 2180929

Related Public Records

Same Entity

tst Biomedical Electronics 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
K790947	Macomb Chemical Co.	AUTO ENZYMATIC CHOLESTEROL	1979-06-28
K885023	Em Diagnostic Systems, Inc.	CHOLESTEROL TEST ITEM NUMBER: SR1011	1989-02-17
K771508	Instrumentation Laboratory CO	MULTISTAT III CHOLESTEROL TEST	1977-09-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2009	Roche Diagnostics Corp.	1	Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol in serum and plasma.

Similar Registrations

Registration Number	Establishment Name	Location
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
2050010	BECKMAN COULTER, INC.	CARLSBAD, CA, US
3004493545	RANDOX LABORATORIES LIMITED	CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
2032900	Diazyme Laboratories, Inc.	POWAY, CA, US
2085064	CLINIQA CORPORATION	San Marcos, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023197868. Last updated year: 2026. Please use registration number 3023197868 when referencing this establishment in official correspondence.