International Enzymes, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What International Enzymes, Inc. makes
International Enzymes, Inc. manufactures laboratory controls and calibration verifiers for clinical chemistry and immunology assays, including high-sensitivity C-reactive protein (HSCRP) controls and clinical protein calibration standards for systems like the Beckman Array 360 and Beckman Array Protein.
These products are regulated as Class I and Class II devices under FDA 510(k) clearance requirements and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Liquid Immunology Control Level I, Ii, Iii Ref K963085
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does International Enzymes, Inc. have in the registry?
The registry currently lists 7 devices for International Enzymes, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list International Enzymes, Inc.'s devices?
Among its 7 most recently registered devices, International Enzymes, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do International Enzymes, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for International Enzymes, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from International Enzymes, Inc. in the registry?
The most recently registered devices listed for International Enzymes, Inc. include HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3, LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM, LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III and LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E.