Data / Medical devices / Hydrazone Colorimetry, Alt/Sgpt
Hydrazone Colorimetry, Alt/Sgpt (CKD): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Hydrazone Colorimetry, Alt/Sgpt (product code CKD, Class 1, 21 CFR 862.1030). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on September 9, 1999, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CKD
- Device class
- 1
- Regulation
- 862.1030
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| China | 4 |
| United States | 1 |
| Egypt | 1 |
| Argentina | 1 |
Makers of Hydrazone Colorimetry, Alt/Sgpt
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 |
|---|---|---|---|---|---|---|---|---|
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 1 | October 13, 1988 | 0 | 0 | 0 | api.fda.gov |
| Debo Medical Technology (shijiazhuang) Co., Ltd. | Shijiazhuang Hebei, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elhoda Trade And Supplies | Badr industerial city Al Qahirah, Egypt | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Prospect Healthcare Co. Ltd | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| URIT Medical Electronic Co., Ltd. | Guilin Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wiener Laboratorios S.A.I.C. | ROSARIO Santa Fe, Argentina | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOGEAR Medical Co., Ltd. | Yizheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 9, 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.