Bion Mumps-G Antibody Test System

• • Terminated Z-1479-2013 FDA Class III ·initiated 23 Jan 2013 ·on shared 510(k) K926066

  Affected products have a labeled expiration date of one year too long.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K926066 ↗

FDA Product Code

CAR

Device Class

Class II

Regulation

21 CFR Part 880.2460

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Bion Borrelia Burgdorferi Antigen Substrate Slide

  Class II

  FDA 510(k) K901054 Active Cleared 5 Apr 1990

• Respiratory Syncytial Virus

  Class I

  FDA 510(k) K894623 Active Cleared 16 Oct 1989

• Bion Direct Identification Control Slide

  Class I

  FDA 510(k) K890616 Active Cleared 17 Feb 1989

• Mumps Virus

  Class I

  FDA 510(k) K894624 Active Cleared 16 Oct 1989

• Epstein-Barr Virus-Nuclear Antigen

  Class I

  FDA 510(k) K894626 Active Cleared 16 Oct 1989

• Bion Antinuclear Antibody(Ana)Test Kit/Contr Serum

  Class II

  FDA 510(k) K872845 Active Cleared 17 Aug 1987

See all devices from Bion Ent., Ltd. →