Synchron Cx Systems Lipase (Lipa) Reagent

• • Terminated Z-0262-5 FDA Unclassified (pre-2012) ·initiated 25 Oct 2004

  Beckman Coulter has confirmed that occasionally a cuvette may be skipped during the SYNCHRON Lipase Wash (LIWA) procedure. If this occurs, there is the potential for carryover into the SYNCHRON Lipase (LIPA) assay, resulting ina substantial positive bias affecting Lipase (LIPA) results.

510(k) Number

K970905 ↗

FDA Product Code

CHI

Device Class

Class I

Regulation

21 CFR Part 862.1465

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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