Hi Chem, Inc.
United StatesFDA applicant, unverified
- Devices
- 52
What Hi Chem, Inc. makes
Hi Chem, Inc. manufactures diagnostic reagents and consumables for laboratory testing, including calcium, bilirubin, electrolyte, and uric acid measurement kits, as well as cleaning and neutralizing solutions for diagnostic equipment. Their portfolio also covers reagent cartridges for automated analyzers and electrolyte gel for sample preparation.
The company’s products are regulated under FDA’s Class I and Class II device classifications, with many authorised via the 510(k) pathway. These items are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Search and filter all 52 devicesDeviceDevice · Authorizations Verified Status Regime Registry Class
CO2 Reference Reagent Ref K791687
Regimes: 510(k) Registry: 510(k)Astra Printer Paper #88112-Chloride Silv Ref K802392
Regimes: 510(k) Registry: 510(k)
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