Bion Ent., Ltd.
Mchenry, IL, US
Bion Ent., Ltd. appears in FDA device records in Mchenry, IL. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Bion Ent., Ltd. between 1980 and 1993. The busiest year on record is 1989, with 8. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 8 |
| 1990 | 1 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K926066 | BION MUMPS-G ANTIBODY TEST SYSTEM | CAR | Substantially Equivalent | |
| K901054 | BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE | LSR | Substantially Equivalent | |
| K894622 | VARICELLA ZOSTER VIRUS | GQW | Substantially Equivalent | |
| K894626 | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN | LLM | Substantially Equivalent | |
| K894624 | MUMPS VIRUS | GRA | Substantially Equivalent | |
| K894623 | RESPIRATORY SYNCYTIAL VIRUS | LKT | Substantially Equivalent | |
| K891785 | BION EBV-G (VCA) TEST SYSTEM | JRY | Substantially Equivalent | |
| K894625 | CHLAMYDIA (LGV-1) | LKI | Substantially Equivalent | |
| K893240 | BION EBV-M (VCA) TEST SYSTEM | LJN | Substantially Equivalent | |
| K890616 | BION DIRECT IDENTIFICATION CONTROL SLIDE | LJG | Substantially Equivalent | |
| K881261 | BION HSV1-G OR HSV2-G TEST SYSTEM | GQO | Substantially Equivalent | |
| K880679 | BION CMV-G TEST SYSTEM | GQH | Substantially Equivalent | |
| K872845 | BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM | DHN | Substantially Equivalent | |
| K800434 | PORTABLE MEDICAL ULTRASOUND SCANNER | IYO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LJNAntibody Igm, If, Epstein-Barr Virus
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GQOAntisera, Cf, Herpesvirus Hominis 1,2
- LKIAntisera, Fluorescent, Chlamydia Spp.
- JRYAntiserum, Fluorescent, Epstein-Barr Virus
- GRAAntiserum, Fluorescent, Mumps Virus
- CARMonitor, Spinal-Fluid Pressure, Electrically Powered
- LJGQuality Control Slides
- LSRReagent, Borrelia Serological Reagent
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Bion Ent., Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Bion Ent., Ltd.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain