Bion Direct Identification Control Slide
FDA 510(k) K890616 · Bion Ent., Ltd.
510(k) numberK890616
Submission
- Device name
- Bion Direct Identification Control Slide
- Applicant
- Bion Ent., Ltd.
Park Ridge, IL, US - Received
- February 7, 1989
- Decision date
- February 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LJG – Quality Control Slides
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code LJG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K943228 | Microsporidium Control SetLJG · Traditional | Meridian Diagnostics, Inc. | 10/27/1994SE |
| K924893 | Microsporidium Control SlideLJG · Traditional | Scientific Device Laboratory, Inc. | 01/15/1993SE |
| K890718 | Gram Stain Control SlideLJG · Traditional | Scientific Device Laboratory, Inc. | 03/16/1989SE |
| K890670 | Cryptosporidium Control SlideLJG · Traditional | Scientific Device Laboratory, Inc. | 03/16/1989SE |
| K883571 | Histo-Check Parasitic Control SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
| K883570 | Histo-Check Fungal Control SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
| K883569 | Histo-Check Gram Negative SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
| K883568 | Histo-Check Acid Fast SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
| K883567 | Histo-Check Legionella Control SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 10/06/1988SE |
| K883208 | Histo-Check SlidesLJG · Traditional | Val Tech Diagnostics, Inc. | 08/25/1988SE |
More from Val Tech Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K926066 | Bion Mumps-G Antibody Test SystemCAR · Traditional | 06/15/1993SE |
| K901054 | Bion Borrelia Burgdorferi Antigen Substrate SlideLSR · Traditional | 04/05/1990SE |
| K894622 | Varicella Zoster VirusGQW · Traditional | 10/24/1989SE |
| K894626 | Epstein-Barr Virus-Nuclear AntigenLLM · Traditional | 10/16/1989SE |
| K894624 | Mumps VirusGRA · Traditional | 10/16/1989SE |
| K894623 | Respiratory Syncytial VirusLKT · Traditional | 10/16/1989SE |
| K891785 | Bion Ebv-G (Vca) Test SystemJRY · Traditional | 08/31/1989SE |
| K894625 | Chlamydia (LGV-1)LKI · Traditional | 08/15/1989SE |
| K893240 | Bion Ebv-M (Vca) Test SystemLJN · Traditional | 07/14/1989SE |
| K881261 | Bion HSV1-G or HSV2-G Test SystemGQO · Traditional | 06/07/1988SE |
Questions and answers
When was Bion Direct Identification Control Slide cleared by the FDA?
Bion Direct Identification Control Slide (K890616) received a 510(k) decision of Substantially Equivalent on February 17, 1989, 10 days after the submission was received.
What is the product code of K890616?
The FDA product code is LJG – Quality Control Slides, a Class I (low risk) device regulated under 21 CFR 866.2660.