Data / Medical devices / Nadh Oxidation/Nad Reduction, Alt/Sgpt / United States
FDA-registered makers of Nadh Oxidation/Nad Reduction, Alt/Sgpt in the United States: 21 establishments
21 establishments in the United States are registered with the FDA to make Nadh Oxidation/Nad Reduction, Alt/Sgpt (product code CKA). 10 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.
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- Device
- Nadh Oxidation/Nad Reduction, Alt/Sgpt
- Product code
- CKA
- Country
- United States
Makers of Nadh Oxidation/Nad Reduction, Alt/Sgpt in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer, Manufacturer | 2 | January 7, 1998 | 0 | 0 | 0 | api.fda.gov |
| Alfa Wassermann | West Caldwell, NJ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | July 19, 2012 | 0 | 1 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 1 | September 21, 1995 | 0 | 0 | 0 | api.fda.gov |
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer | 1 | December 31, 1981 | 0 | 0 | 0 | api.fda.gov |
| Cliniqa Corporation | San Marcos, CA, United States | Contract manufacturer, Manufacturer | 1 | March 15, 1982 | 0 | 0 | 0 | api.fda.gov |
| Carolina Liquid Chemistries | Brea, CA, United States | Manufacturer | 1 | February 18, 1997 | 0 | 0 | 0 | api.fda.gov |
| Horiba Instruments Incorporated | Canton, MI, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | May 3, 1994 | 0 | 1 | 0 | api.fda.gov |
| Infrared Laboratory Systems dba SYNERMED | Westfield, IN, United States | Manufacturer | 1 | May 7, 1992 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 1 | May 10, 2006 | 0 | 0 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 1 | December 31, 1986 | 0 | 0 | 0 | api.fda.gov |
| Abaxis, Inc. | Union City, CA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Currier Plastics | Auburn, NY, United States | Contract 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 | |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Inc. (Chicago) | Gurnee, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov |
Updated November 2, 2026. 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.