Data / Medical devices / Alcohol Control Materials
Alcohol Control Materials (DKC): 7 FDA-registered makers in 2 countries
7 establishments in 2 countries are registered with the FDA to make Alcohol Control Materials (product code DKC, Class 1, 21 CFR 862.3280). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on July 1, 2003, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DKC
- Device class
- 1
- Regulation
- 862.3280
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Germany | 1 |
Makers of Alcohol Control Materials
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 |
|---|---|---|---|---|---|---|---|---|
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 1 | October 27, 1993 | 0 | 0 | 0 | api.fda.gov |
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer | 1 | July 26, 1991 | 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. | 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 | |
| Lin-Zhi International, Inc. | Santa Clara, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microgenics Corporation | Fremont, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 1, 2003. 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.