Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065
FDA 510(k) K032166 · Binax, Inc.
510(k) numberK032166
Submission
- Device name
- Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065
- Applicant
- Binax, Inc.
Portland, ME, US - Received
- July 16, 2003
- Decision date
- October 21, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K090301 | Binaxnow PBP2A Test, Model 890-000MYI · Traditional | 04/14/2010SE |
| K091766 | Clearview Exact PBP2A Test, Model 891-000MYI · Traditional | 02/24/2010SE |
| K090964 | Binaxnox Staphylococcus Aureus TestJWX · Traditional | 12/16/2009SE |
| K091489 | Clearview Advanced Strep a , Model 737-430GTY · Traditional | 09/04/2009SE |
| K083744 | Binaxnow Malaria Positive Control Kit, Model 665-010MJZ · Traditional | 09/01/2009SE |
| K092223 | Modification to: Binaxnow Influenza a & B TestPSZ · Special | 08/12/2009SE |
| K080003 | Binaxnow G6PD TestJBF · Traditional | 10/23/2008SE |
| K062109 | Binaxnow Influenza a & B TestPSZ · Traditional | 11/09/2006SE |
| K053126 | Binaxnow Influenza a & B TestPSZ · Traditional | 11/30/2005SE |
| K041049 | Binaxnow Influenza a & B TestPSZ · Traditional | 08/10/2004SE |
Questions and answers
When was Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065 cleared by the FDA?
Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065 (K032166) received a 510(k) decision of Substantially Equivalent on October 21, 2003, 97 days after the submission was received.
What is the product code of K032166?
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.