Data / Medical devices / Calibrator For Red-Cell And White-Cell Counting
Calibrator For Red-Cell And White-Cell Counting (KSA): 11 FDA-registered makers in 3 countries
11 establishments in 3 countries are registered with the FDA to make Calibrator For Red-Cell And White-Cell Counting (product code KSA, Class 2, 21 CFR 864.8185). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on December 15, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KSA
- Device class
- 2
- Regulation
- 864.8185
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Japan | 1 |
| France | 1 |
Makers of Calibrator For Red-Cell And White-Cell Counting
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 |
|---|---|---|---|---|---|---|---|---|
| R & D Systems, Inc. | Minneapolis, MN, United States | Manufacturer | 1 | May 2, 1988 | 0 | 0 | 0 | api.fda.gov |
| Streck LLC | La Vista, NE, United States | Contract manufacturer, Manufacturer | 1 | December 15, 1994 | 0 | 0 | 0 | api.fda.gov |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 1 | December 15, 1994 | 0 | 0 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinical Diagnostic Solutions, Inc. | Plantation, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horiba Abx SAS | MONTPELLIER Herault, France | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horiba Instruments Incorporated | Canton, MI, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract 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 | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 15, 1994. 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.