Data / Medical devices / Calibrators, Drug Mixture / United States
FDA-registered makers of Calibrators, Drug Mixture in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Calibrators, Drug Mixture (product code DKB). 6 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Calibrators, Drug Mixture
- Product code
- DKB
- Country
- United States
Makers of Calibrators, Drug Mixture in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Contract manufacturer, Manufacturer, Specification developer | 6 | September 14, 2006 | 0 | 1 | 0 | api.fda.gov |
| Microgenics Corporation | Fremont, CA, United States | Contract manufacturer, Manufacturer | 3 | November 5, 1998 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 2 | January 11, 2000 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | September 12, 2001 | 0 | 0 | 0 | api.fda.gov |
| Infrared Laboratory Systems dba SYNERMED | Westfield, IN, United States | Manufacturer | 1 | February 21, 2014 | 0 | 0 | 0 | api.fda.gov |
| Lin-Zhi International, Inc. | Santa Clara, CA, United States | Manufacturer | 1 | February 21, 2014 | 0 | 2 | 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 | |
| DTPM Inc. | Fort Payne, AL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 1 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 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.