K122718 is an FDA 510(k) clearance for the BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP. This device is classified as a Antigens, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTY).
Submitted by Becton, Dickinson and Company (San Diego, US). The FDA issued a Cleared decision on February 6, 2013, 154 days after receiving the submission on September 5, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K122718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2012 |
| Decision Date | February 06, 2013 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GTY — Antigens, All Groups, Streptococcus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |