510(k) K191967
K191967 is an FDA 510(k) premarket notification submitted by Curetis GmbH for the device "Unyvero LRT BAL Application". The FDA issued a decision of Substantially Equivalent on December 20, 2019. The device falls under product code QBH (Lower Respiratory Microbial Nucleic Acid Detection System), a Class II device regulated under 21 CFR 866.3985. Curetis GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2019
- Date Received
- July 23, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lower Respiratory Microbial Nucleic Acid Detection System
- Device Class
- Class II
- Regulation Number
- 866.3985
- Review Panel
- MI
- Submission Type
Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.