Bion Ent., Ltd.
Bion Ent., Ltd. appears in FDA public data with 0 recalls, 14 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 15, 1993.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 14
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K926066 | BION MUMPS-G ANTIBODY TEST SYSTEM | June 15, 1993 |
| K901054 | BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE | April 5, 1990 |
| K894622 | VARICELLA ZOSTER VIRUS | October 24, 1989 |
| K894623 | RESPIRATORY SYNCYTIAL VIRUS | October 16, 1989 |
| K894626 | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN | October 16, 1989 |
| K894624 | MUMPS VIRUS | October 16, 1989 |
| K891785 | BION EBV-G (VCA) TEST SYSTEM | August 31, 1989 |
| K894625 | CHLAMYDIA (LGV-1) | August 15, 1989 |
| K893240 | BION EBV-M (VCA) TEST SYSTEM | July 14, 1989 |
| K890616 | BION DIRECT IDENTIFICATION CONTROL SLIDE | February 17, 1989 |
| K881261 | BION HSV1-G OR HSV2-G TEST SYSTEM | June 7, 1988 |
| K880679 | BION CMV-G TEST SYSTEM | June 3, 1988 |
| K872845 | BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM | August 17, 1987 |
| K800434 | PORTABLE MEDICAL ULTRASOUND SCANNER | April 10, 1980 |