Company ยท US
Bion Ent., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1993. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CAR | Monitor, Spinal-Fluid Pressure, Electrically Powered | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 1 |
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | 1 |
| GRA | Antiserum, Fluorescent, Mumps Virus | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 |
| JRY | Antiserum, Fluorescent, Epstein-Barr Virus | 1 |
| LJG | Quality Control Slides | 1 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 1 |
| LKI | Antisera, Fluorescent, Chlamydia Spp. | 1 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 1 |
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | 1 |
| LSR | Reagent, Borrelia Serological Reagent | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 1993 | K926066 | BION MUMPS-G ANTIBODY TEST SYSTEM Bion Ent., Ltd. | CAR |
| Apr 5, 1990 | K901054 | BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE Bion Ent., Ltd. | LSR |
| Oct 24, 1989 | K894622 | VARICELLA ZOSTER VIRUS Bion Ent., Ltd. | GQW |
| Oct 16, 1989 | K894626 | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN Bion Ent., Ltd. | LLM |
| Oct 16, 1989 | K894624 | MUMPS VIRUS Bion Ent., Ltd. | GRA |
| Oct 16, 1989 | K894623 | RESPIRATORY SYNCYTIAL VIRUS Bion Ent., Ltd. | LKT |
| Aug 31, 1989 | K891785 | BION EBV-G (VCA) TEST SYSTEM Bion Ent., Ltd. | JRY |
| Aug 15, 1989 | K894625 | CHLAMYDIA (LGV-1) Bion Ent., Ltd. | LKI |
| Jul 14, 1989 | K893240 | BION EBV-M (VCA) TEST SYSTEM Bion Ent., Ltd. | LJN |
| Feb 17, 1989 | K890616 | BION DIRECT IDENTIFICATION CONTROL SLIDE Bion Ent., Ltd. | LJG |
| Jun 7, 1988 | K881261 | BION HSV1-G OR HSV2-G TEST SYSTEM Bion Ent., Ltd. | GQO |
| Jun 3, 1988 | K880679 | BION CMV-G TEST SYSTEM Bion Ent., Ltd. | GQH |
| Aug 17, 1987 | K872845 | BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM Bion Ent., Ltd. | DHN |
| Apr 10, 1980 | K800434 | PORTABLE MEDICAL ULTRASOUND SCANNER Bion Ent., Ltd. | IYO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||