ARKRAY Industry West Inc.

FDA Device Registration & Listing · Rosario Cavite, PH · Registration 3013472743

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
3013472743
FEI Number
3013472743
Entity Name
ARKRAY Industry West Inc.
City/State/Country
Rosario Cavite, PH
Establishment Address
Main Avenue Cor. 3rd Street CEZ, Rosario Cavite 4106, PH
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ARKRAY Industry West,Inc. (Owner Number: 10053944)
Owner / Operator Contact Address
Main Avenue Cor. 3rd Street CEZ, Rosario, PH-CAV 4106, PH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K221175
PMA Number
N/A

All Registered Proprietary Names

ReliOn Premier Voice Blood Glucose Monitoring System GLUCOCARD Vital BGM System ASSURE PLATINUM BGM SYSTEM ReliOn Premier Classic Blood Glucose Monitoring System ReliOn Premier Compact Blood Glucose Monitoring System Multi-Lancet Device 2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2022-04-07
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2017-09-04
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-09-04
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-09-04
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2017-01-25
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2017-01-25
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2017-01-25
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-10-27
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2018-08-22
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2022-11-21

Official Correspondent

No official correspondent registered.

US Agent Details

Yosuke Yamamoto Business: ARKRAY Factory USA, Inc. Email: yamamotoy@arkrayusa.com Phone: (612) 9461481

Related Public Records

Same Entity

ARKRAY Industry West,Inc.
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
K150396 Apex BioTechnology Corp. Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips 2015-10-14
K150833 Andon Health Co, Ltd. iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System 2015-12-04
K811074 Reagents Applications, Inc. GLUCOSE REAGENT-ENZYMATIC-COLOR 500 1981-04-29
K936212 Heraeus Kulzer, Inc. GLUCOFILM TEST STRIPS 1994-05-10
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
Z-0044-06 Abbott Laboratories Medisense Products 2
Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0378-06 Instrumentation Laboratory Co. 2
GEM PREMIER 3000

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013472743. Last updated year: 2026. Please use registration number 3013472743 when referencing this establishment in official correspondence.
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