Alko Diagnostic Corp.
United StatesFDA applicant, unverified
- Devices
- 31
What Alko Diagnostic Corp. makes
Alko Diagnostic Corp. manufactures calibration solutions, reagents, and control products for clinical chemistry analyzers, including electrolyte instruments, blood gas analyzers, and co-oximeters. Their offerings include ISE (ion-selective electrode) calibrants and reagents for systems like Hitachi, Baxter Paramax, Corning 600 Series, and DuPont Dimension, as well as pH control products for blood gas analyzers. Additional products include electrolyte buffers, CO₂ reagents, and calibration fluids for Amdev Lytening systems.
The company’s portfolio is regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. Products are listed in the FDA’s 510(k) registry. Alko Diagnostic Corp. is based in the United States.
Catalogue
Search and filter all 31 devicesFrequently asked questions
How many devices does Alko Diagnostic Corp. have in the registry?
The registry currently lists 31 devices for Alko Diagnostic Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alko Diagnostic Corp.'s devices?
Among its 31 most recently registered devices, Alko Diagnostic Corp. has devices listed in FDA 510(k) (31 devices).
What risk classes do Alko Diagnostic Corp.'s devices fall under?
Among its 31 most recently registered devices, the classes recorded for Alko Diagnostic Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alko Diagnostic Corp. in the registry?
The most recently registered devices listed for Alko Diagnostic Corp. include CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR, REAGENTS FOR HITACHI ISE, ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM and PH BLOOD GAS CONTROL PRODUCTS.