Icn Pharmaceuticals, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 30
What Icn Pharmaceuticals, Inc. makes
Icn Pharmaceuticals, Inc. manufactures diagnostic reagents and chemistry controls for clinical laboratory testing, including enzyme-based assays for creatine phosphokinase (CPK) and glutamic oxaloacetic transaminase (GOT), as well as total and direct glucose and cholesterol measurement procedures. The company also produces sponges for tissue dissection, such as the ICAN K and SUAN Flat variants, and enzymatic controls for alkaline phosphatase testing. Additional offerings include water column relief valves and direct measurement reagents for inorganic phosphorus.
The company’s products are classified under FDA’s Class I and Class II regulatory categories, with most devices listed via the 510(k) pathway. These items are intended for use in clinical chemistry and pathology settings, adhering to U.S. regulatory standards. The manufacturer is based in the United States.
Catalogue
Search and filter all 30 devicesFrequently asked questions
How many devices does Icn Pharmaceuticals, Inc. have in the registry?
The registry currently lists 30 devices for Icn Pharmaceuticals, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Icn Pharmaceuticals, Inc.'s devices?
Among its 30 most recently registered devices, Icn Pharmaceuticals, Inc. has devices listed in FDA 510(k) (30 devices).
What risk classes do Icn Pharmaceuticals, Inc.'s devices fall under?
Among its 30 most recently registered devices, the classes recorded for Icn Pharmaceuticals, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Icn Pharmaceuticals, Inc. in the registry?
The most recently registered devices listed for Icn Pharmaceuticals, Inc. include REAGENT CPK, ENZYME, CHOLESTEROL PROCEDURE, TEKPOINT TOTAL, GLUCOSE PROCEDURE, TEKPOINT DIRECT and REAGENT GOT, ENZYME.