Chem-Elec, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Chem-Elec, Inc. makes
Chem-Elec, Inc. makes reagents and kits for various medical tests, including glucose, sodium, potassium, chloride, and cholesterol tests, as well as devices such as the Chemcard glucose test and the Astra device.
The company's portfolio is regulated under Class I and Class II devices and is listed in the FDA 510(k) registry, with the company based in the US.
Catalogue
Bun Rate Reagent Ref K811193
Regimes: 510(k) Registry: 510(k)Sodium/Potassium Reagent Kits Ref K811310
Regimes: 510(k) Registry: 510(k)Chemcard Glucose Test Ref K943503
Regimes: 510(k) Registry: 510(k)Glucose Oxidase Rate Reagent Ref K811165
Regimes: 510(k) Registry: 510(k)Chloride Reagent Kit Ref K811319
Regimes: 510(k) Registry: 510(k)Astra Ref K811381
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Creatinine Rate Reagent Kit Ref K811406
Regimes: 510(k) Registry: 510(k)Chloride/Carbon Dioxide Rate Reagent Ref K811701
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Chem-Elec, Inc. have in the registry?
The registry currently lists 9 devices for Chem-Elec, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Chem-Elec, Inc.'s devices?
Among its 9 most recently registered devices, Chem-Elec, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Chem-Elec, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Chem-Elec, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Chem-Elec, Inc. in the registry?
The most recently registered devices listed for Chem-Elec, Inc. include BUN RATE REAGENT, SODIUM/POTASSIUM REAGENT KITS, CHEMCARD GLUCOSE TEST and GLUCOSE OXIDASE RATE REAGENT.