Thrombo Screen Sickle Cell Assay Set

• • Terminated Z-1496-04 FDA Unclassified (pre-2012) ·initiated 3 Sep 2004

  Defective reaction vials from an in vitro diagnostic test kit may cause positive patient samples to be interpreted as false negatives.

510(k) Number

K854079 ↗

FDA Product Code

GHM

Device Class

Class II

Regulation

21 CFR Part 864.7825

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

• Thromboscreen Thromboplastin-Ds

  Class II

  FDA 510(k) K940082 Active Cleared 14 Feb 1995

• 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

See all devices from Pacific Hemostasis →