DEN170047 is an FDA 510(k) submission for the Curetis Unyvero LRT Application. This device is classified as a Lower Respiratory Microbial Nucleic Acid Detection System (Class II - Special Controls, product code QBH).
Submitted by Curetis GmbH (Holzgerlingen, DE). The FDA issued a Not Cleared (DENG) decision on April 3, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3985. Device To Detect And Identify Microorganisms And Associated Resistance Marker Nucleic Acids Directly In Respiratory Specimens..
| 510(k) Number | DEN170047 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 11, 2017 |
| Decision Date | April 03, 2018 |
| Days to Decision | 204 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | QBH - Lower Respiratory Microbial Nucleic Acid Detection System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3985 |
| Definition | Device To Detect And Identify Microorganisms And Associated Resistance Marker Nucleic Acids Directly In Respiratory Specimens. |