Mach Diag. C/O Wichita State University
Country not established
- Devices
- 2
What Mach Diag. C/O Wichita State University makes
Mach Diag. produces urine chemistry analyzers (URI-CHEM® series) for rapid, multi-parameter testing of urine samples, including models for general chemistry and specialized metrics. They also manufacture blood glucose strips (DEXPAD) for point-of-care glucose monitoring.
The company’s devices are classified as Class I and Class II under FDA regulations, with submissions recorded via 510(k) pathways. Their products are listed in the FDA’s regulatory database, and the manufacturer is based in the United States.
Catalogue
Uri-Chem(R) Gk, 2, 3, 4C, 5CN, 6C, 7C And 8C Ref K880584
Regimes: 510(k) Registry: 510(k)Dexpad, Blood Glucose Strip Ref K880585
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mach Diag. C/O Wichita State University have in the registry?
The registry currently lists 2 devices for Mach Diag. C/O Wichita State University. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mach Diag. C/O Wichita State University's devices?
Among its 2 most recently registered devices, Mach Diag. C/O Wichita State University has devices listed in FDA 510(k) (2 devices).
What risk classes do Mach Diag. C/O Wichita State University's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Mach Diag. C/O Wichita State University's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mach Diag. C/O Wichita State University in the registry?
The most recently registered devices listed for Mach Diag. C/O Wichita State University include URI-CHEM(R) GK, 2, 3, 4C, 5CN, 6C, 7C AND 8C and DEXPAD, BLOOD GLUCOSE STRIP.