Chronimed, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Chronimed, Inc. makes
Chronimed, Inc. manufactures diagnostic reagents and blood glucose monitoring systems, including reagent strips, control solutions, and meters for self-testing glucose levels. Their products include the DIASCREEN reagent strips, SUPREME II control solutions and meters, and the QUICKTEK blood glucose system with associated strips and controls. The SENSOREX system also provides continuous blood glucose monitoring components.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the 510(k) database. These products are intended for in vitro diagnostic use in the United States, where Chronimed, Inc. is based.
Catalogue
Diascreen Reagent Strips Ref K981555
Regimes: 510(k) Registry: 510(k)Supreme Ii Control Solutions Ref K983432
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Sensorex Blood Glucose Monitoring System Ref K980573
Regimes: 510(k) Registry: 510(k)Supreme Ii Meter Ref K963544
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Chronimed, Inc. have in the registry?
The registry currently lists 5 devices for Chronimed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Chronimed, Inc.'s devices?
Among its 5 most recently registered devices, Chronimed, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Chronimed, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Chronimed, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Chronimed, Inc. in the registry?
The most recently registered devices listed for Chronimed, Inc. include DIASCREEN REAGENT STRIPS, SUPREME II CONTROL SOLUTIONS, QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION and SENSOREX BLOOD GLUCOSE MONITORING SYSTEM.