Respiratory Syncytial Virus

No FDA recalls found in the data synced 12 Oct 2026.

510(k) Number

K894623 ↗

FDA Product Code

LKT

Device Class

Class I

Regulation

21 CFR Part 866.3480

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Bion Borrelia Burgdorferi Antigen Substrate Slide

  Class II

  FDA 510(k) K901054 Active Cleared 5 Apr 1990

• Bion Mumps-G Antibody Test System

  Class II

  FDA 510(k) K926066 Active Cleared 15 Jun 1993

• 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. →