Thromboscreen Thromboplastin-Ds

• • Terminated Z-1519-2011 FDA Unclassified (pre-2012) ·initiated 6 Oct 2010

  An in vitro diagnostic reagent used in coagulation testing may cause inaccurate clotting times in quality control and patient plasma samples.

510(k) Number

K940082 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Prothrombin Reference Plasma (Human)

  Class II

  FDA 510(k) K791022 Active Cleared 24 Jul 1979

• Pacific Hemostasis Immunodepleted Factor V Deficient Plasma (Thrombosdreen Brand) (100056)

  Class II

  FDA 510(k) K972627 Active Cleared 13 Aug 1997

• Thrombostrate Control Plasmas

  Class II

  FDA 510(k) K000679 Active Cleared 24 Mar 2000

• Antithrombin III Screen Kit

  Class II

  FDA 510(k) K812215 Active Cleared 1 Sep 1981

• Thromboscreen Aptt Reagent

  Class II

  FDA 510(k) K891337 Active Cleared 21 Apr 1989

• Heparin Control Plasma Level 1

  Class II

  FDA 510(k) K992278 Active Cleared 26 Aug 1999

See all devices from Pacific Hemostasis →