Data / Medical devices / Calibrator For Hemoglobin And Hematocrit Measurement / United States
FDA-registered makers of Calibrator For Hemoglobin And Hematocrit Measurement in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Calibrator For Hemoglobin And Hematocrit Measurement (product code KRZ). 2 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Calibrator For Hemoglobin And Hematocrit Measurement
- Product code
- KRZ
- Country
- United States
Makers of Calibrator For Hemoglobin And Hematocrit Measurement in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Clinical Diagnostic Solutions, Inc. | Plantation, FL, United States | Manufacturer, Repackager or relabeler | 1 | June 10, 2004 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | February 21, 1984 | 0 | 1 | 0 | api.fda.gov |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio-Rad Laboratories, Inc. | Hercules, CA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Waltham, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| R & D Systems, Inc. | Minneapolis, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Streck LLC | La Vista, NE, United States | 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 |
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.