A-Kem, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 13
What A-Kem, Inc. makes
A-Kem, Inc. makes reagent kits for various medical tests, including sodium/potassium, carbon dioxide, glucose, and other laboratory tests. Their products include calibrator standard kits and wash solution kits for use with specific systems. The company's reagent kits are designed for testing different substances, such as calcium, total protein, total bilirubin, albumin, creatinine, and chloride.
A-Kem, Inc.'s portfolio is regulated under Class I and Class II device classes and is listed in the FDA 510(k) registry. The company is based in the US.
Catalogue
Search and filter all 13 devicesFrequently asked questions
How many devices does A-Kem, Inc. have in the registry?
The registry currently lists 13 devices for A-Kem, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list A-Kem, Inc.'s devices?
Among its 13 most recently registered devices, A-Kem, Inc. has devices listed in FDA 510(k) (13 devices).
What risk classes do A-Kem, Inc.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for A-Kem, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from A-Kem, Inc. in the registry?
The most recently registered devices listed for A-Kem, Inc. include SODIUM/POTASSIUM REAGENT KIT, CARBON DIOXIDE REAGENT KIT, GLUCOSE REAGENT KIT and CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM.