Data / Medical devices / Calibrators, Ethyl Alcohol
Calibrators, Ethyl Alcohol (DNN): 10 FDA-registered makers in 3 countries
10 establishments in 3 countries are registered with the FDA to make Calibrators, Ethyl Alcohol (product code DNN, Class 2, 21 CFR 862.3200). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on March 31, 1999, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DNN
- Device class
- 2
- Regulation
- 862.3200
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Germany | 1 |
| China | 1 |
Makers of Calibrators, Ethyl Alcohol
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 |
|---|---|---|---|---|---|---|---|---|
| Microgenics Corporation | Fremont, CA, United States | Contract manufacturer, Manufacturer | 1 | December 9, 1992 | 0 | 0 | 0 | api.fda.gov |
| Verichem Laboratories, Inc. | Providence, RI, United States | Manufacturer | 1 | August 4, 1988 | 0 | 0 | 0 | api.fda.gov |
| Alere San Diego, Inc. | Pomona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chromsystems Instruments & Chemicals GMBH | Gräfelfing Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eterbio, Inc. | Zhuhai Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lin-Zhi International, Inc. | Santa Clara, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 31, 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.