Spectrolyse Antithrombin III (Anti-Xa)

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K960871 ↗

FDA Product Code

JBQ

Device Class

Class II

Regulation

21 CFR Part 864.7060

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Aspartate Aminotransferase Reagent System

  Class II

  FDA 510(k) K952743 Active Cleared 29 Sep 1995

• Factor XII Deficient Plasma

  Class II

  FDA 510(k) K893534 Active Cleared 23 Jun 1989

• Borrelia Burgdorferi Igm Antibody Test System

  Class II

  FDA 510(k) K885294 Active Cleared 10 Apr 1989

• Cytomegalovirus Control Slides

  Class II

  FDA 510(k) K873114 Active Cleared 25 Sep 1987

• Factor VII Deficient Plasma

  Class II

  FDA 510(k) K893535 Active Cleared 23 Jun 1989

• Normal Coagulation Control Plasma (Nccp)

  Class II

  FDA 510(k) K895262 Active Cleared 6 Oct 1989

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