Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008877272

FEI Number

3008877272

Entity Name

GENERAL LIFE BIOTECHNOLOGY CO., LTD.

City/State/Country

New Taipei City, TW

Establishment Address

6, 7F., No. 669, Jhongjheng Rd., Shin Juang Dist., New Taipei City 242060, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

General Life Biotechnology Co., Ltd. (Owner Number: 10043132)

Owner / Operator Contact Address

7F., No. 669, Jhongjheng Rd., Shin Juang Dist., New Taipei City, TW-NWT 242051, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BeneCheck Total Cholesterol test strip BeneCheck Knight BT Blood B-Ketone Monitoring System BeneCheck Knight Blood B-Ketone Monitoring System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2013-01-28
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2022-03-09

Official Correspondent

Mary Hu

US Agent Details

Marissa Vilchez Email: m.vilchez@mdssar.com Phone: (312) 9751694

Related Public Records

Same Entity

General Life 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
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

Similar Registrations

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9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
1181121	Fisher Diagnostics	MIDDLETOWN, VA, US
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
1423455	HOME ACCESS HEALTH CORP.	Hoffman Est, IL, US
3005644014	VISGENEER, INC.	HSINCHU CITY Hsinchu (City), TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008877272. Last updated year: 2026. Please use registration number 3008877272 when referencing this establishment in official correspondence.