Data / Medical devices / Calibrator For Hemoglobin And Hematocrit Measurement
Calibrator For Hemoglobin And Hematocrit Measurement (KRZ): 14 FDA-registered makers in 3 countries
14 establishments in 3 countries are registered with the FDA to make Calibrator For Hemoglobin And Hematocrit Measurement (product code KRZ, Class 2, 21 CFR 864.8165). 3 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 25 510(k) clearances under this code, the latest on August 26, 2005, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KRZ
- Device class
- 2
- Regulation
- 864.8165
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| Germany | 1 |
| France | 1 |
Makers of Calibrator For Hemoglobin And Hematocrit Measurement
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 |
|---|---|---|---|---|---|---|---|---|
| Clinical Diagnostic Solutions, Inc. | Plantation, FL, United States | Manufacturer, Repackager or relabeler | 1 | June 10, 2004 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 1 | August 26, 2005 | 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 | |
| Horiba Abx SAS | MONTPELLIER Herault, France | 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 | |
| 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 August 26, 2005. 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.