Cholestech Ldx Aspartate Aminotransferase (Ast)

• • Terminated Z-1139-2013 FDA Class II ·initiated 6 Mar 2013 ·on shared 510(k) K032027

  The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K032027 ↗

FDA Product Code

CIS

Device Class

Class II

Regulation

21 CFR Part 862.1100

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K922612 Active Cleared 24 Jun 1992

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  FDA 510(k) K946063 Active Cleared 22 Feb 1995

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• Cholestech L.D.X. Level 1 Control

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  FDA 510(k) K904784 Active Cleared 18 Dec 1990

See all devices from Cholestech Corp. →