Data / Medical devices / Solution, Isotonic / United States
FDA-registered makers of Solution, Isotonic in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Solution, Isotonic (product code JCE). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Solution, Isotonic
- Product code
- JCE
- Country
- United States
Makers of Solution, Isotonic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Analytichem Usa, Inc. | Winslow, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hardy Diagnostics | Orcutt, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hardy Diagnostics | Springboro, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Michclone Associates, Inc. | Troy, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Newcomer Supply Inc | Waunakee, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ricca Chemical Company LLC | Pocomoke City, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ricca Chemical Company LLC | Arlington, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ricca Chemical Company LLC | Batesville, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wavesense, Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.