Data / Medical devices / Formalin, Neutral Buffered
Formalin, Neutral Buffered (IFP): 28 FDA-registered makers in 5 countries
28 establishments in 5 countries are registered with the FDA to make Formalin, Neutral Buffered (product code IFP, Class 1, 21 CFR 864.4010). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on January 10, 1989, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IFP
- Device class
- 1
- Regulation
- 864.4010
- Medical specialty
- Pathology
Makers by country
| Country | Makers |
|---|---|
| United States | 22 |
| Canada | 3 |
| South Korea | 1 |
| Germany | 1 |
| Australia | 1 |
Makers of Formalin, Neutral Buffered
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 |
|---|---|---|---|---|---|---|---|---|
| ANATECH division of Cancer Diagnostics, Inc. | Battle Creek, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Azer Scientific, Inc. | Morgantown, PA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chaptec America | Montreal Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creative Waste Solutions, Inc. | Tualatin, OR, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CalibreScientific US, Inc. | Vancouver, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cancer Diagnostics, Inc. | Durham, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E K Industries, Inc. | Joliet, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ENG Scientific LLC | New Brunswick, NJ, 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 | |
| GD Group Co., Ltd. | Eumseong Chungbuk, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Les Plastiques MDJ Inc. | Saint-Hubert Quebec, Canada | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Biosystems Richmond, Inc. | Richmond, IL, United States | 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 | |
| Merck Kgaa | DARMSTADT Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Newcomer Supply Inc | Waunakee, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Medical Devices Inc | New Brunswick, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remel, Inc. | Lenexa, KS, United States | Manufacturer | 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 | |
| Richard-Allan Scientific LLC | Kalamazoo, MI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Rocky Mountain Reagents, Inc. | Golden, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sakura Finetek U.s.a., Inc. | Torrance, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scytek Laboratories, Inc. | Logan, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Simport Scientific Inc. | BELOEIL Quebec, Canada | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SLMP LLC d.b.a. StatLab Medical Products | McKinney, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trajan Scientific Australia Pty Ltd | Ringwood Victoria, Australia | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 10, 1989. 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.