Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009129531

FEI Number

3009129531

Entity Name

GL DIABETES CORPORATION

City/State/Country

San Diego, CA, US

Establishment Address

9676 Oviedo St, San Diego, CA 92129, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GL DIABETES CORPORATION (Owner Number: 10035802)

Owner / Operator Contact Address

9676 Oviedo St., San Diego, CA 92129, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Loris Safety Lancet GoodLife Lancing Device GoodLife Safety Lancet GoodLife Lancet SteriLance Lancing Device GlucoLeader Lancet GlucoLeader Lancing Device Tianjin Huahong Lancet PRECICHEK NS-101 PRECICHEK Cloudia Goodlife AC-300~306 Blood Glucose Monitoring System(NFC) GlucoLeader Value GoodLife AC300~AC305 Blood Glucose Monitoring Sysytem GoodLife AC300~AC305 Professional Blood Glucose Monitoring System Rosie SmartMeter Blood Glucose Monitoring System Goodlife Cs-200 FIA Biomed Salut Blood Glucose Monitoring System FIA Biomed Salut Professional Blood Glucose Monitoring System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2015-01-07
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-01-08
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-01-08
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-01-08
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-01-08
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2015-01-08
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-11-19
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2015-11-19
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-01-08
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2015-01-08
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2014-12-30
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2014-12-30
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-12-30
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-01-08
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2015-01-08

Official Correspondent

Tina Jair

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GL DIABETES CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003902721	HMD BIOMEDICAL, INC.	Hsinchu County, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009129531. Last updated year: 2026. Please use registration number 3009129531 when referencing this establishment in official correspondence.