Data / Medical devices / Solution, Formalin-Sodium Acetate / United States
FDA-registered makers of Solution, Formalin-Sodium Acetate in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Solution, Formalin-Sodium Acetate (product code IGB). 1 has 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, Formalin-Sodium Acetate
- Product code
- IGB
- Country
- United States
Makers of Solution, Formalin-Sodium Acetate in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Remel, Inc. | Lenexa, KS, United States | Manufacturer | 1 | December 22, 1980 | 0 | 0 | 0 | api.fda.gov |
| Azer Scientific, Inc. | Morgantown, PA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CalibreScientific US, Inc. | Vancouver, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethos Biosciences, INC. | Logan Township, NJ, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Chemical Corporation | Torrance, CA, United States | Manufacturer, Repackager or relabeler | 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.