Clotting Factor-VIII-IX-XI-XII Deficient Plasma

• • Terminated Z-1713-2015 FDA Class II ·initiated 11 May 2015

  Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results at the lower end of the measuring range.

• • Terminated Z-1374-05 FDA Unclassified (pre-2012) ·initiated 8 Jul 2005

  sample may exhibit falsely high results

510(k) Number

K924396 ↗

FDA Product Code

GJT

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Clibration Plasmas

  Class II

  FDA 510(k) K924404 Active Cleared 1 Dec 1992

• Opus Ck-Mb & Total Ck Controls

  Class I

  FDA 510(k) K960275 Active Cleared 25 Apr 1996

• D.A.T. (Tm) Amylase Reagent

  Class II

  FDA 510(k) K871943 Active Cleared 3 Jun 1987

• N/T Protein Control Sl

  Class I

  FDA 510(k) K964065 Active Cleared 6 Nov 1996

• Enzygnost(R) Anti-Cmv Igg

  Class II

  FDA 510(k) K913910 Active Cleared 28 Apr 1992

• N/T Rheumatology Control Sl/1 and Sl/2

  Class II

  FDA 510(k) K962373 Active Cleared 11 Jul 1996

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