K121633 is an FDA 510(k) clearance for the BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV. This device is classified as a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I - General Controls, product code GQG).
Submitted by Becton, Dickinson and Company (San Diego, US). The FDA issued a Cleared decision on September 18, 2012, 106 days after receiving the submission on June 4, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3480.
| 510(k) Number | K121633 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2012 |
| Decision Date | September 18, 2012 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GQG — Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3480 |