Olympus Triglyceride Test System

• • Terminated Z-1934-2016 FDA Class II ·initiated 13 Apr 2016

  Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.

510(k) Number

K063804 ↗

FDA Product Code

CDT

Device Class

Class I

Regulation

21 CFR Part 862.1705

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K951445 Active Cleared 3 May 1995

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  Class II

  FDA 510(k) K950786 Active Cleared 6 Mar 1995

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