Data / Medical devices / Calibrator For Cell Indices
Calibrator For Cell Indices (KRX): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Calibrator For Cell Indices (product code KRX, Class 2, 21 CFR 864.8150). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on December 22, 2016, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KRX
- Device class
- 2
- Regulation
- 864.8150
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Japan | 1 |
| France | 1 |
| China | 1 |
Makers of Calibrator For Cell Indices
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 |
|---|---|---|---|---|---|---|---|---|
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 3 | October 22, 2012 | 0 | 0 | 0 | api.fda.gov |
| 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 |
| Horiba Abx SAS | MONTPELLIER Herault, France | Repackager or relabeler, Specification developer | 1 | February 29, 1996 | 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 |
| B&e Bio-Technology Co., Ltd. | Yantai Shandong, China | Manufacturer | 0 | 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 December 22, 2016. 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.