Data / Medical devices / Electrolyte Controls (Assayed And Unassayed)
Electrolyte Controls (Assayed And Unassayed) (JJR): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Electrolyte Controls (Assayed And Unassayed) (product code JJR, Class 1, 21 CFR 862.1660). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on April 27, 1999, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JJR
- Device class
- 1
- Regulation
- 862.1660
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 3 |
| Canada | 1 |
| India | 1 |
Makers of Electrolyte Controls (Assayed And Unassayed)
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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Point Of Care Canada Limited | Ottawa Ontario, Canada | Specification developer | 1 | March 1, 1996 | 0 | 0 | 0 | api.fda.gov |
| Opti Medical Systems Inc. | Roswell, GA, United States | Specification developer | 1 | March 24, 1988 | 0 | 0 | 0 | api.fda.gov |
| Quantimetrix Corp. | Redondo Beach, CA, United States | Manufacturer | 1 | October 4, 1994 | 0 | 0 | 0 | api.fda.gov |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist., Chongqing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dirui Industrial Co., Ltd. | CHANGCHUN Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infitek Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lords Mark Industries Ltd. | Daman and Diu Dadra and Nagar Haveli, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 27, 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.