Medical Device Manufacturer · US , Mchenry , IL

Bion Ent., Ltd.

14 submissions · 14 cleared · Since 1980

14

Total

14

Cleared

0

Denied

Bion Ent., Ltd. — FDA 510(k) Submissions

Bion Ent., Ltd. has submitted 14 FDA 510(k) premarket notifications since 1980, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Antiserum, Fluorescent, Epstein-barr Virus, Antibody Igm, If, Epstein-barr Virus, Antigen, Cf, (including Cf Control), Varicella-zoster, Respiratory Syncytial Virus, Antigen, Antibody, Ifa, Antiserum, Fluorescent, Mumps Virus . Use the specialty filter in the sidebar to narrow results.

14 devices

1–14 of 14

BION MUMPS-G ANTIBODY TEST SYSTEM

K926066 · CAR Monitor, Spinal-fluid... · Microbiology

BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE

K901054 · LSR Reagent, Borrelia... · Microbiology

VARICELLA ZOSTER VIRUS

K894622 · GQW Antigen, Cf, (including... · Microbiology

RESPIRATORY SYNCYTIAL VIRUS

K894623 · LKT Respiratory Syncytial... · Microbiology

K894624 · GRA Antiserum, Fluorescent,... · Microbiology

EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN

K894626 · LLM Test, Antigen, Nuclear,... · Microbiology

BION EBV-G (VCA) TEST SYSTEM

K891785 · JRY Antiserum, Fluorescent,... · Microbiology

CHLAMYDIA (LGV-1)

K894625 · LKI Antisera, Fluorescent,... · Microbiology

BION EBV-M (VCA) TEST SYSTEM

K893240 · LJN Antibody Igm, If,... · Microbiology

BION DIRECT IDENTIFICATION CONTROL SLIDE

K890616 · LJG Quality Control Slides · Microbiology

BION HSV1-G OR HSV2-G TEST SYSTEM

K881261 · GQO Antisera, Cf, Herpesvirus... · Microbiology

BION CMV-G TEST SYSTEM

K880679 · GQH Antigen, Cf (including Cf... · Microbiology

BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM

K872845 · DHN Antinuclear Antibody,... · Immunology

PORTABLE MEDICAL ULTRASOUND SCANNER

K800434 · IYO System, Imaging, Pulsed... · Radiology