Data / Medical devices / Japan / Furuno Electric Co., Ltd.
Furuno Electric Co., Ltd.: FDA-registered device maker in NISHINOMIYA-CITY Hyogo, Japan, 4 510(k) clearances
Furuno Electric Co., Ltd. is registered with the FDA (registration 3004438098) in NISHINOMIYA-CITY Hyogo, Japan. It lists 11 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 20, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004438098
- Address
- 2-20, Nishinomiyahama, NISHINOMIYA-CITY Hyogo, Japan, 662-0934
- Owner or operator
- Furuno Electric Co., Ltd. (9048176)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 10, 2012
- Registered through
- 2026
- Brand names listed
- Poly-Chem, Poly-Chem 90, RX Daytona, RX Imola
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | 1 | Manufacturer | accessdata.fda.gov |
| Calibrator, Multi-Analyte Mixture | JIX | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion Specific, Potassium | CEM | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion Specific, Sodium | JGS | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion-Specific, Chloride | CGZ | 2 | Manufacturer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Manufacturer | accessdata.fda.gov |
| Hexokinase, Glucose | CFR | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Photometric Method, Magnesium | JGJ | 1 | 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 20, 2009 | K090703 | POLY-CHEM 90 GLUCOSE | CFR | Substantially Equivalent | Polymedco, Inc. | accessdata.fda.gov |
| March 31, 2006 | K052914 | RX IMOLA | CEM | Substantially Equivalent | Randox Laboratories, Ltd. | accessdata.fda.gov |
| December 4, 2003 | K024014 | RANDOX RX DAYTONA | CGA | Substantially Equivalent | Randox Laboratories, Ltd. | accessdata.fda.gov |
| July 3, 2002 | K020852 | POLY-CHEM GLUCOSE | CFR | Substantially Equivalent | Polymedco, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Glucose Oxidase, Glucose
- All makers of Electrode, Ion-Specific, Chloride
- All makers of Analyzer, Chemistry, Micro, For Clinical Use
- All makers of Calibrator, Multi-Analyte Mixture
- All makers of Electrode, Ion Specific, Sodium
- All makers of Electrode, Ion Specific, Potassium
Updated October 20, 2009. 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.