Data / Medical devices / Calibrator For Cell Indices / United States
FDA-registered makers of Calibrator For Cell Indices in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Calibrator For Cell Indices (product code KRX). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Calibrator For Cell Indices
- Product code
- KRX
- Country
- United States
Makers of Calibrator For Cell Indices in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| R & D Systems, Inc. | Minneapolis, MN, United States | Contract manufacturer, Manufacturer | 2 | January 16, 2001 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 1 | April 4, 2002 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Miami, FL, United States | Specification developer | 1 | July 9, 1991 | 0 | 0 | 0 | api.fda.gov |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 1 | February 29, 1996 | 0 | 0 | 0 | api.fda.gov |
| Streck LLC | La Vista, NE, United States | Contract manufacturer, Manufacturer | 1 | February 3, 2009 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | February 29, 1996 | 0 | 0 | 0 | api.fda.gov |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 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.