Data / Medical devices / Whole Blood Hemoglobin Determination
Whole Blood Hemoglobin Determination (KHG): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Whole Blood Hemoglobin Determination (product code KHG, Class 2, 21 CFR 864.7500). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 39 510(k) clearances under this code, the latest on September 29, 2023, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KHG
- Device class
- 2
- Regulation
- 864.7500
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 1 |
| Switzerland | 1 |
Makers of Whole Blood Hemoglobin Determination
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 |
|---|---|---|---|---|---|---|---|---|
| Analytical Control Systems | Fishers, IN, United States | Manufacturer | 2 | November 12, 1980 | 0 | 0 | 0 | api.fda.gov |
| Horiba Instruments Incorporated | Canton, MI, United States | Manufacturer | 1 | July 12, 1985 | 0 | 0 | 0 | api.fda.gov |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer, Repackager or relabeler | 1 | February 11, 2002 | 0 | 0 | 0 | api.fda.gov |
| Ekf Diagnostic GMBH | BARLEBEN/MADGEBURG Saxony-Anhalt, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 29, 2023. 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.