Data / Medical devices / Control, Cell Counter, Normal And Abnormal
Control, Cell Counter, Normal And Abnormal (JCN): 9 FDA-registered makers in 3 countries
9 establishments in 3 countries are registered with the FDA to make Control, Cell Counter, Normal And Abnormal (product code JCN, Class 2, 21 CFR 864.8625). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on November 30, 1999, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JCN
- Device class
- 2
- Regulation
- 864.8625
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| India | 2 |
| China | 1 |
Makers of Control, Cell Counter, Normal And Abnormal
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 |
|---|---|---|---|---|---|---|---|---|
| Streck LLC | La Vista, NE, United States | Contract manufacturer, Manufacturer | 2 | November 30, 1999 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 2 | November 30, 1999 | 0 | 1 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 1 | August 22, 1990 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 1 | August 22, 1990 | 0 | 0 | 0 | api.fda.gov |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marken Healthtech Limited | NASHIK Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onechipdx Biotech (suzhou) Co., Ltd | Suzhou Jiangsu, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R & D Systems, Inc. | Minneapolis, MN, United States | Contract manufacturer, 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 30, 1999. 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.