Wako Lipid Control, Level 1 and Level 2

• • Terminated Z-1792-2010 FDA Unclassified (pre-2012) ·initiated 5 Feb 2010 ·via K040918, on the same 510(k)

  Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K040918 ↗

FDA Product Code

JJX

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Wako Direct Bilirubin V

  Class II

  FDA 510(k) K970986 Active Cleared 7 May 1997

• Wako Autokit CH50

  Class II

  FDA 510(k) K954145 Active Cleared 18 Dec 1995

• Wako Total Bilirubin V

  Class II

  FDA 510(k) K970985 Active Cleared 21 Apr 1997

• Wako Nefa Linearity Set

  Class I

  FDA 510(k) K030065 Active Cleared 11 Feb 2003

• Total Bilirubin Standard Calibrator

  Class II

  FDA 510(k) K872263 Active Cleared 22 Jul 1987

• Wako Autokit Apo A1

  Class I

  FDA 510(k) K952615 Active Cleared 8 Sep 1995

See all devices from Wako Chemicals USA, Inc. →