Data / Medical devices / Osmometer For Clinical Use
Osmometer For Clinical Use (JJM): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Osmometer For Clinical Use (product code JJM, Class 1, 21 CFR 862.2730). 0 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on February 20, 1997, and lists 2 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- JJM
- Device class
- 1
- Regulation
- 862.2730
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 4 |
| Germany | 1 |
| Indonesia | 1 |
Makers of Osmometer For Clinical Use
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Advanced Instruments, LLC | Norwood, MA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| ELITechGroup Inc | Logan, UT, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MBH | Berlin, Germany | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Four E's Scientific Co., Ltd. | GUANGZHOU Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infitek Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labpeak Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MX3 Diagnostics, Inc. | Austin, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Systems, Inc. | Natick, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT OSI Electronics | Batam Centre Riau, Indonesia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scitek Global Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 20, 1997. 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.