Hemochron(R) Heparin Response Test

• • Terminated Z-2110-2010 FDA Unclassified (pre-2012) ·initiated 24 Jun 2010

  An ingredient in the RQCHRT Whole Blood Controls for use with Hemochron Kaolin and Celite HRT Test tubes may become less potent over time and result in excessive High LQC Failures.

510(k) Number

K904003 ↗

FDA Product Code

KFF

Device Class

Class II

Regulation

21 CFR Part 864.7525

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Modified Ivt Peripheral Atherectomy

  Class II

  FDA 510(k) K901767 Active Cleared 28 Jun 1990

• Ivt Introducer Sheath

  Class II

  FDA 510(k) K903463 Active Cleared 3 Jan 1991

• Peripheral Atherectomy System

  Class II

  FDA 510(k) K890515 Active Cleared 23 May 1989

• Aptt by Hemochron(R)

  Class II

  FDA 510(k) K892209 Active Cleared 22 Jun 1989

• Modified Ivt Peripheral Atherectomy System

  Class II

  FDA 510(k) K896403 Active Cleared 6 Mar 1990

• Tec Rotating Dual Hemovalve

  Class II

  FDA 510(k) K912664 Active Cleared 24 Aug 1992

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