Data / Medical devices / Japan / Jeol Ltd.
Jeol Ltd.: FDA-registered device maker in Musashimurayama Tokyo, Japan, 1 510(k) clearance
Jeol Ltd. is registered with the FDA (registration 3003637681) in Musashimurayama Tokyo, Japan. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 21, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003637681
- Address
- 2-11-1 Inadaira, Musashimurayama Tokyo, Japan, 208-0023
- Owner or operator
- JEOL LTD. (9051046)
- Roles
- Manufacturer
- First device listed
- July 9, 2012
- Registered through
- 2026
- Brand names listed
- BM Test BATH FLUID 50, Chloride Electrode, Cuvette Conditioner 3, Cuvette Conditioner EX, Cuvette Wash Solution 3, Cuvette Wash Solution 7, ISE Buffer (IS), ISE Detergent Solution and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| Calibrator, Multi-Analyte Mixture | JIX | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion Selective (Non-Specified) | JJP | 1 | 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 |
| General Purpose Reagent | PPM | 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 |
|---|---|---|---|---|---|---|
| May 21, 1999 | K990346 | BAYER ADVIA 1650 CHEMISTRY SYSTEM | JGS | Substantially Equivalent | Bayer Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Calibrator, Multi-Analyte Mixture
- All makers of Electrode, Ion Specific, Sodium
- All makers of Electrode, Ion-Specific, Chloride
- All makers of Electrode, Ion Specific, Potassium
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Electrode, Ion Selective (Non-Specified)
Updated May 21, 1999. 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.