Data / Medical devices / Control, Hemoglobin, Abnormal
Control, Hemoglobin, Abnormal (JCM): 6 FDA-registered makers in 4 countries
6 establishments in 4 countries are registered with the FDA to make Control, Hemoglobin, Abnormal (product code JCM, Class 2, 21 CFR 864.7415). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on December 7, 2005, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JCM
- Device class
- 2
- Regulation
- 864.7415
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| New Zealand | 1 |
| France | 1 |
| Finland | 1 |
Makers of Control, Hemoglobin, 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 |
|---|---|---|---|---|---|---|---|---|
| Canterbury Scientific Ltd. | Christchurch Canterbury, New Zealand | Manufacturer | 2 | December 7, 2005 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 1 | June 10, 1991 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 1 | June 10, 1991 | 0 | 0 | 0 | api.fda.gov |
| Sebia | EVRY Essonne, France | Manufacturer | 1 | December 7, 2005 | 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 | |
| Wallac OY | TURKU Varsinais-Suomi, Finland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 7, 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.