RSV Antigen Control Slides
FDA 510(k) K964870 · Viral Antigens, Inc.
510(k) numberK964870
Submission
- Device name
- RSV Antigen Control Slides
- Applicant
- Viral Antigens, Inc.
Memphis, TN, US - Received
- December 5, 1996
- Decision date
- March 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GQG – Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3480
- Specialty
- Microbiology
Other 510(k)s with product code GQG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253318 | Clungene RSV Antigen Rapid TestGQG · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 01/30/2026SE |
| K240280 | Nano-Check RSV TestGQG · Dual Track | Nano-Ditech Corporation | 07/30/2024SE |
| K162911 | Sofia RSV FIA on Sofia 2 analyzerGQG · Traditional | Quidel Corporation | 02/22/2017SE |
| K133140 | BD Veritor System for the Rapid Detection of RSVGQG · Special | Becton, Dickinson & CO | 11/15/2013SE |
| K132456 | BD Veritor (TM) System for Rapid Detection of RSVGQG · Traditional | Becton, Dickinson and Company | 11/07/2013SE |
| K130398 | Sofia(R) RSV FiaGQG · Traditional | Quidel Corp. | 08/13/2013SE |
| K121633 | BD Veritor(Tm) System for the Rapid Detection of RSVGQG · Traditional | Becton, Dickinson and Company | 09/18/2012SE |
| K101918 | Quickvue RSV 10GQG · Traditional | Quidel Corp. | 09/24/2010SE |
| K101514 | BD Directigen Ez RSVGQG · Traditional | Becton, Dickinson & CO | 07/09/2010SE |
| K091235 | Ramp RSV AssayGQG · Traditional | Response Biomedical Corp. | 07/24/2009SE |
More from Response Biomedical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K971101 | HSV-2 Antigen Control SlidesGQN · Traditional | 07/01/1997SE |
| K964874 | HSV-1 Antigen Control SlidesGQN · Traditional | 07/01/1997SE |
| K964875 | CMV Antigen Control SlidesGQH · Traditional | 03/18/1997SE |
| K964872 | VZV Antigen Control SlidesGQW · Traditional | 03/18/1997SE |
| K903882 | Varicella-Zoster Virus Antibody Test Kit-Latex AggGQW · Traditional | 12/04/1990SE |
Questions and answers
When was RSV Antigen Control Slides cleared by the FDA?
RSV Antigen Control Slides (K964870) received a 510(k) decision of Substantially Equivalent on March 18, 1997, 103 days after the submission was received.
What is the product code of K964870?
The FDA product code is GQG – Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus, a Class I (low risk) device regulated under 21 CFR 866.3480.