Bc Thrombin Reagent

• • Terminated Z-0827-2018 FDA Class II ·initiated 17 Oct 2017

  The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT) results for expected normal samples, and may recover above the upper limit of normal (< 21 sec.) as stated within the IFU (Instruction For Use).

• • Terminated Z-0007-05 FDA Unclassified (pre-2012) ·initiated 21 Jul 2004

  The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin

510(k) Number

K970645 ↗

FDA Product Code

GJA

Device Class

Class II

Regulation

21 CFR Part 864.7875

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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