K121710 is an FDA 510(k) clearance for the XPERT CT/NG. This device is classified as a Dna-reagents, Neisseria (Class II - Special Controls, product code LSL).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on December 27, 2012, 199 days after receiving the submission on June 11, 2012.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K121710 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2012 |
| Decision Date | December 27, 2012 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LSL — Dna-reagents, Neisseria |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3390 |