Immulite Progesterone

• • Terminated Z-0524-2009 FDA Unclassified (pre-2012) ·initiated 21 Jul 2008

  Siemens Healthcare Diagnostics has confirmed a long-standing high bias with LKPG 1, 5. (The bias is approximately 25% at 10 - 20 ng/mL as opposed to approximately 3% at 1-3 ng/mL - for more detail see the bias plot that is included with this notice.).

510(k) Number

K944211 ↗

FDA Product Code

JLS

Device Class

Class I

Regulation

21 CFR Part 862.1620

Advisory Committee

Clinical Chemistry

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

See all devices from Diagnostic Products Corp. →