Respiratory Syncytial Virus
FDA 510(k) K894623 · Bion Ent., Ltd.
510(k) numberK894623
Submission
- Device name
- Respiratory Syncytial Virus
- Applicant
- Bion Ent., Ltd.
Park Ridge, IL, US - Received
- July 20, 1989
- Decision date
- October 16, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKT – Respiratory Syncytial Virus, Antigen, Antibody, Ifa
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3480
- Specialty
- Microbiology
Other 510(k)s with product code LKT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081928 | D3 Duet Dfa Rsv/Respiratory Virus Screening KitLKT · Traditional | Diagnostic Hybrids, Inc. | 12/23/2008SE |
| K983336 | Pathodx Respiratory Virus Panel Model PKRP1LKT · Traditional | Diagnostic Products Corp. | 03/18/1999SE |
| K943317 | Pathodx Respiratory Syncytial Virus (RSV)LKT · Traditional | Diagnostic Products Corp. | 12/19/1994SE |
| K942173 | RSV Antigen TestLKT · Traditional | Neogenex | 06/30/1994SE |
| K912842 | Rsv-Mab TestLKT · Traditional | Gull Laboratories, Inc. | 12/09/1991SE |
| K912838 | Bartels Respiratory Syncytial Virus Enzyme ImmunoLKT · Traditional | Baxter Diagnostics, Inc. | 09/27/1991SE |
| K912371 | Biomerieux RSV Direct If KitLKT · Traditional | Vitek Systems, Inc. | 09/23/1991SE |
| K884192 | RSV Ifa Test Kit for Direct Antigen DetectionLKT · Traditional | Baxter Diagnostics, Inc. | 11/22/1988SE |
| K882687 | Anti-Respiratory Syncytial Virus Antibody TestLKT · Traditional | Gull Laboratories, Inc. | 08/30/1988SE |
| K873564 | Genetic Systems RSV Reagent Control SlidesLKT · Traditional | Genetic Systems Corp. | 11/20/1987SE |
More from Genetic Systems Corp.
| 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 |
| 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 |
| K890616 | Bion Direct Identification Control SlideLJG · Traditional | 02/17/1989SE |
| K881261 | Bion HSV1-G or HSV2-G Test SystemGQO · Traditional | 06/07/1988SE |
Questions and answers
When was Respiratory Syncytial Virus cleared by the FDA?
Respiratory Syncytial Virus (K894623) received a 510(k) decision of Substantially Equivalent on October 16, 1989, 88 days after the submission was received.
What is the product code of K894623?
The FDA product code is LKT – Respiratory Syncytial Virus, Antigen, Antibody, Ifa, a Class I (low risk) device regulated under 21 CFR 866.3480.