Data / Medical devices / Taiwan / Global Instrumentation Corp.
Global Instrumentation Corp.: FDA-registered device maker in New Taipei, Taiwan, 2 510(k) clearances
Global Instrumentation Corp. is registered with the FDA (registration 9710595) in New Taipei, Taiwan. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 17, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710595
- FEI number
- 3003400058
- Address
- 14 F., No. 186, Jian-Yi Road Chung-Ho District, New Taipei, Taiwan, 235
- Owner or operator
- GLOBAL INSTRUMENTATION CORP. (9046757)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- January 23, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | 2 | Exporter to the US | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | 1 | Contract manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Contract manufacturer, Exporter to the US | 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, 2013 | K131013 | FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Nova Biomedical Corporation | accessdata.fda.gov |
| July 11, 2007 | K070960 | NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM | CGA | Substantially Equivalent | Nova Biomedical Corp. | 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 Glucose Dehydrogenase, Glucose
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Nitroprusside, Ketones (Urinary, Non-Quant.)
Updated October 17, 2013. 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.