Data / Medical devices / Mixture, Hematology Quality Control
Mixture, Hematology Quality Control (JPK): 22 FDA-registered makers in 4 countries
22 establishments in 4 countries are registered with the FDA to make Mixture, Hematology Quality Control (product code JPK, Class 2, 21 CFR 864.8625). 12 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 192 510(k) clearances under this code, the latest on December 22, 2016, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JPK
- Device class
- 2
- Regulation
- 864.8625
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 19 |
| Japan | 1 |
| France | 1 |
| China | 1 |
Makers of Mixture, Hematology Quality Control
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 | Contract manufacturer, Manufacturer | 26 | September 1, 2016 | 0 | 2 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 11 | January 29, 2010 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 11 | January 29, 2010 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Miami, FL, United States | Manufacturer, Specification developer | 9 | February 3, 2009 | 0 | 0 | 0 | api.fda.gov |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 7 | December 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Horiba Abx SAS | MONTPELLIER Herault, France | Complaint file establishment, Repackager or relabeler, Specification developer | 4 | July 10, 2006 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 4 | September 24, 2002 | 0 | 0 | 0 | api.fda.gov |
| Streck LLC | La Vista, NE, United States | Contract manufacturer, Manufacturer | 2 | February 23, 2007 | 0 | 0 | 0 | api.fda.gov |
| Bionostics, Inc. | Devens, MA, United States | Manufacturer | 1 | September 19, 1985 | 0 | 0 | 0 | api.fda.gov |
| Clinical Diagnostic Solutions, Inc. | Plantation, FL, United States | Manufacturer, Repackager or relabeler | 1 | January 14, 2003 | 0 | 3 | 0 | api.fda.gov |
| Horiba Instruments Incorporated | Canton, MI, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | April 24, 1980 | 0 | 0 | 0 | api.fda.gov |
| Microgenics Corporation | Fremont, CA, United States | Manufacturer | 1 | September 19, 1985 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instruments, LLC | Norwood, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B&e Bio-Technology Co., Ltd. | Yantai Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Hialeah, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton Dickinson Caribe, LTD | Cayey, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson and Company, BD Biosciences | Milpitas, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Waltham, MA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer, Manufacturer for export, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quantimetrix Corp. | Redondo Beach, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 1 | 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 | |
| Sure-Tech Diagnostic Associates, Inc. | Saint Louis, MO, United States | Manufacturer | 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.