Bion Ent., Ltd.: FDA clearances and approvals
Bion Ent., Ltd. has 14 FDA 510(k) clearances (first 1980, latest 1993), across 14 product codes in 4 review panels. Median 510(k) review time: 82 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAR | Monitor, Spinal-Fluid Pressure, Electrically Powered | 1 | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 | 1 |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 1 | 1 |
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | 1 | 1 |
| GRA | Antiserum, Fluorescent, Mumps Virus | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| JRY | Antiserum, Fluorescent, Epstein-Barr Virus | 1 | 1 |
| LJG | Quality Control Slides | 1 | 1 |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 1 | 1 |
Plus 4 more product codes.
Review panels
- Microbiology (11)
- General Hospital (1)
- Immunology (1)
- Radiology (1)
Most recent Bion Ent., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K926066 | BION MUMPS-G ANTIBODY TEST SYSTEM | CAR | 1993-06-15 | 196 |
| K901054 | BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE | LSR | 1990-04-05 | 30 |
| K894622 | VARICELLA ZOSTER VIRUS | GQW | 1989-10-24 | 96 |
| K894626 | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN | LLM | 1989-10-16 | 88 |
| K894624 | MUMPS VIRUS | GRA | 1989-10-16 | 88 |
| K894623 | RESPIRATORY SYNCYTIAL VIRUS | LKT | 1989-10-16 | 88 |
| K891785 | BION EBV-G (VCA) TEST SYSTEM | JRY | 1989-08-31 | 160 |
| K894625 | CHLAMYDIA (LGV-1) | LKI | 1989-08-15 | 26 |
| K893240 | BION EBV-M (VCA) TEST SYSTEM | LJN | 1989-07-14 | 77 |
| K890616 | BION DIRECT IDENTIFICATION CONTROL SLIDE | LJG | 1989-02-17 | 10 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bion Ent., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bion Ent., Ltd. have?
Bion Ent., Ltd. has 14 FDA 510(k) clearances (first 1980, latest 1993), across 14 product codes in 4 review panels.
How long does FDA take to clear Bion Ent., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Bion Ent., Ltd.'s cleared 510(k)s is 82 days.
What devices does Bion Ent., Ltd. make?
Its most frequent FDA product codes are CAR (Monitor, Spinal-Fluid Pressure, Electrically Powered, 1); DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 1); GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus, 1).
Has Bion Ent., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bion Ent., Ltd. Related entities may recall under other names.
Next steps
- See all 14 Bion Ent., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CAR, Bion Ent., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.