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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.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue52

Newest first, rows 1-50 of 52

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  • Astra-T Calcium Reagent Ref K820090

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cholar Produ&T #17010 Ref K771731

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Direct Bilirubin Reagent Ref K841572

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cholorde Reagent Ref K791690

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hilar Ref K782094

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ast Reagent Cartridge Ref K861283

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Electrolyte Gel Ref K813370

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hi Chem Diagnostics Cleaning Neutralizer SOL#88193 Ref K853003

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ion 4 Sodium/Potassium/Chloride/Total Ref K842025

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Uricar Ref K812700

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ldp Reagent Cartridge (No. 88216) Ref K862027

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Alkaline Buffer Ref K791688

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Amylase Reagent #88129 Ref K831295

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Potassium Electrode Tip Assambly-K- Ref K833159

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hichem Enzyme Verifier Kit Ref K943684

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ck Reagent Cartridge (Product No. 88213) Ref K861879

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • CO2 Cup Reagent Ref K791686

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hi Chem Diagnostics Ldl Reagent Cartridge Ref K861419

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Calibrator I Ref K791693

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hichem Calcium Reagent For The Synchron CX3 Prod. No. 88808 Ref K941764

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hi-Chem Diagnostics Enzyme Rinse Concentrate Ref K852867

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Wash Solution Kit, #88102 Ref K802264

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Total Bilirubin Reagent Ref K830714

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bun Reagent Kit #88108 Ref K800616

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Fast Flow #60310 Ref K791365

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sodium/Potassium Conditioning Solution Ref K791691

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ion 2/4 Flow Cell Cleaner (Product #88656) Ref K863617

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hi Chem Total Protein/Albumin Serum Range Lin Stnd Ref K902673

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Contro I Ref K791695

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ion 2 Reagent Ki Ref K851350

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Calibrator A Ref K830137

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Calibrator B 88133 Ref K850405

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Alt Reagent Cartridge (Product No. 88210) Ref K861231

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ap Reagent Cartridge Ref K861284

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hichem Ion 2/4 Urine Range Calibrator Ref K842450

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Astra Total Protein Reagent Ref K813536

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sodium/Potassium Buffer Solution Ref K791692

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hichem Glucose/Hk Reagent Kit Ref K960084

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ggt Reagent Cartridge (Product No. 88204) Ref K861893

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Calibrator Ii Ref K791694

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cleaning Reagent Kit Product No 88194 Ref K855196

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Contro Ii Ref K791696

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Chemlar Ref K781132

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Trendar Ref K771000

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Picric Solution Ref K791689

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Albumin Reagent Ref K821225

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hichem Alt Reagent Kit Ref K951818

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Hichem Ion 2/4 Serum Range Calibrator Ref K842449

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Klinar Reagent Pak, #36010 Ref K801892

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Glucose Reagent Ref K791685

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-50 of 52

Showing 1-50 of 52

Frequently asked questions

How many devices does Hi Chem, Inc. have in the registry?

The registry currently lists 52 devices for Hi Chem, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hi Chem, Inc.'s devices?

Among its 50 most recently registered devices, Hi Chem, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Hi Chem, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Hi Chem, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Hi Chem, Inc. in the registry?

The most recently registered devices listed for Hi Chem, Inc. include ASTRA-T CALCIUM REAGENT, CHOLAR PRODU&T #17010, DIRECT BILIRUBIN REAGENT and CHOLORDE REAGENT.

Generated automatically from registry data and not verified by a human reviewer.