Olympus Magnesium Reagent

• • Terminated Z-0692-2022 FDA Class II ·initiated 8 Dec 2021

  Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is only to the clinical interpretation of magnesium results in the presence of lipemia.

510(k) Number

K944407 ↗

FDA Product Code

JGJ

Device Class

Class I

Regulation

21 CFR Part 862.1495

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Olympus Unsaturated Iron Binding Capacity Reagent

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  Class II

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• Olympus Biopsy Forceps Model Fb-44

  Class II

  FDA 510(k) K950786 Active Cleared 6 Mar 1995

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