Immilite Total Ige

• • Terminated Z-1517-2014 FDA Class II ·initiated 20 Dec 2013

  Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.

510(k) Number

K960067 ↗

FDA Product Code

JHR

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Immulite 2000 3RD Generation Psa

  Class II

  FDA 510(k) K974842 Active Cleared 21 Apr 1998

• Immulite Turbo Ck-Mb, Models LSKCP1, LSKCP5

  Class II

  FDA 510(k) K991797 Active Cleared 9 Jun 1999

• Coat-A-Count T4 Ria Kit

  Class II

  FDA 510(k) K811315 Active Cleared 27 May 1981

• Immulite(R) Tbg

  Class I

  FDA 510(k) K950072 Active Cleared 3 Apr 1995

• Immulite 2000 Digoxin, Models L2KDI2 (200 Tests) and L2KDI6 (600 Tests)

  Class II

  FDA 510(k) K012301 Active Cleared 19 Sep 2001

• Coat-A-Count Direct Androstenedione

  Class I

  FDA 510(k) K954755 Active Cleared 29 Nov 1995

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