Data / Medical devices / Philippines / ARKRAY Industry West Inc.
ARKRAY Industry West Inc.: FDA-registered device maker in Rosario Cavite, Philippines, 4 510(k) clearances
ARKRAY Industry West Inc. is registered with the FDA (registration 3013472743) in Rosario Cavite, Philippines. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 17, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013472743
- Address
- Main Avenue Cor. 3rd Street CEZ, Rosario Cavite, Philippines, 4106
- Owner or operator
- ARKRAY Industry West,Inc. (10053944)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 25, 2017
- Registered through
- 2026
- Brand names listed
- ASSURE PLATINUM BGM SYSTEM, Assure Titanium Blood Glucose Monitoring System, GLUCOCARD Vital BGM System, Lancet, Multi-Lancet Device 2, ReliOn Premier Classic Blood Glucose Monitoring System, ReliOn Premier Compact Blood Glucose Monitoring System, ReliOn Premier Voice Blood Glucose Monitoring System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | 2 | Manufacturer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Manufacturer | accessdata.fda.gov |
| Prescription Use Blood Glucose Meter For Near-Patient Testing | PZI | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 17, 2022 | K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | QRL | Substantially Equivalent | Arkray, Inc. | accessdata.fda.gov |
| May 23, 2022 | K200788 | Assure Titanium Blood Glucose Monitoring System | PZI | Substantially Equivalent | Arkray, Inc. | accessdata.fda.gov |
| November 24, 2009 | K092104 | ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | Arkray Factory USA, Inc. | accessdata.fda.gov |
| October 23, 2009 | K091102 | ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS | CGA | Substantially Equivalent | Arkray Factory USA, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Glucose Oxidase, Glucose
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Prescription Use Blood Glucose Meter For Near-Patient Testing
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Updated October 17, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.