Data / Medical devices / Formaldehyde (Formalin, Formol)
Formaldehyde (Formalin, Formol) (IGG): 12 FDA-registered makers in 2 countries
12 establishments in 2 countries are registered with the FDA to make Formaldehyde (Formalin, Formol) (product code IGG, Class 1, 21 CFR 864.4010). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on June 15, 1988, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IGG
- Device class
- 1
- Regulation
- 864.4010
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Canada | 1 |
Makers of Formaldehyde (Formalin, Formol)
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 |
|---|---|---|---|---|---|---|---|---|
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 2 | January 21, 1980 | 0 | 1 | 0 | api.fda.gov |
| ANATECH division of Cancer Diagnostics, Inc. | Battle Creek, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chaptec America | Montreal Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cancer Diagnostics, Inc. | Durham, NC, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| E K Industries, Inc. | Joliet, IL, 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 | 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 | |
| SLMP LLC d.b.a. StatLab Medical Products | McKinney, TX, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 15, 1988. 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.