Data / Medical devices / Control, Hemoglobin
Control, Hemoglobin (GGM): 16 FDA-registered makers in 7 countries
16 establishments in 7 countries are registered with the FDA to make Control, Hemoglobin (product code GGM, Class 2, 21 CFR 864.8625). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on November 15, 2019, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GGM
- Device class
- 2
- Regulation
- 864.8625
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| China | 2 |
| Germany | 2 |
| Netherlands | 1 |
| South Korea | 1 |
| India | 1 |
| United Kingdom | 1 |
Makers of Control, Hemoglobin
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 |
|---|---|---|---|---|---|---|---|---|
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 3 | April 2, 2007 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 3 | April 2, 2007 | 0 | 0 | 0 | api.fda.gov |
| Eurotrol B.V. | EDE Gelderland, Netherlands | Contract manufacturer, Manufacturer | 3 | November 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| R & D Systems, Inc. | Minneapolis, MN, United States | Manufacturer | 2 | March 29, 2007 | 0 | 0 | 0 | api.fda.gov |
| Acon Biotech (hangzhou) Co., Ltd. | HANGZHOU Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acon Laboratories, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boditech Med Inc. | Chuncheon Gangwon, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ekf Diagnostic GMBH | BARLEBEN/MADGEBURG Saxony-Anhalt, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunostics, Inc. | Eatontown, NJ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer, Repackager or relabeler | 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 | |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| URIT Medical Electronic Co., Ltd. | Guilin Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 15, 2019. 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.