Ischemia Technologies, Inc.
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- Devices
- 1
What Ischemia Technologies, Inc. makes
Ischemia Technologies, Inc. manufactures the Albumin Cobalt Binding Test (ACB Test), a diagnostic device used to measure albumin-bound cobalt levels in blood samples for clinical assessment.
The ACB Test is classified as a Class II device under FDA regulations and is listed via the 510(k) clearance process. The company is based in the United States.
Catalogue
Albumin Cobalt Binding Test (Acb Test) Ref K023824
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ischemia Technologies, Inc. have in the registry?
The registry currently lists 1 device for Ischemia Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ischemia Technologies, Inc.'s devices?
Among its 1 most recently registered device, Ischemia Technologies, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Ischemia Technologies, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ischemia Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ischemia Technologies, Inc. in the registry?
The most recently registered devices listed for Ischemia Technologies, Inc. include ALBUMIN COBALT BINDING TEST (ACB TEST).