K191967 is an FDA 510(k) clearance for the Unyvero LRT BAL 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 Cleared decision on December 20, 2019, 150 days after receiving the submission on July 23, 2019.
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 | K191967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2019 |
| Decision Date | December 20, 2019 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| 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. |