Data / Medical devices / Orange G
Orange G (HZH): 10 FDA-registered makers in 2 countries
10 establishments in 2 countries are registered with the FDA to make Orange G (product code HZH, Class 1, 21 CFR 864.1850). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on September 7, 1984, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HZH
- Device class
- 1
- Regulation
- 864.1850
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Germany | 1 |
Makers of Orange G
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 |
|---|---|---|---|---|---|---|---|---|
| Azer Scientific, Inc. | Morgantown, PA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cancer Diagnostics, Inc. | Durham, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E K Industries, Inc. | Joliet, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Biosystems Richmond, Inc. | Richmond, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merck Kgaa | DARMSTADT Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Newcomer Supply Inc | Waunakee, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scytek Laboratories, Inc. | Logan, UT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SLMP LLC d.b.a. StatLab Medical Products | McKinney, TX, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SSN Solutions | Henrico, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volusol | Tooele, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 7, 1984. 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.