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Lkb Instruments, Inc.

United StatesFDA applicant, unverified

Devices
52

What Lkb Instruments, Inc. makes

LKB Instruments, Inc. manufactures ultraviolet and visible spectrophotometry systems, including the Ultrospec series and Novaspec, used for measuring light absorption in biochemical and clinical applications. The company also produces immunoassay kits under the Delfia™ brand, including tests for thyroxine (T4), ferritin, human chorionic gonadotropin (HCG), and other biomarkers. Additional products include specialized metabolic analysis tools, such as the Engstrom Metabolic Computer, and a gamma counter for radioactive sample analysis.

The company’s devices are classified under FDA’s Class I and Class II categories, with relevant products listed via the 510(k) pathway. These instruments and kits are intended for in vitro diagnostic use and are regulated under the U.S. Food and Drug Administration’s medical device authorities. LKB Instruments, Inc. is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue52

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  • Lkb-Wallace 1251 Luminometer Ref K820217

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

  • Lkb 4460 Fluorimeter Ref K811019

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

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