510(k) DEN170047
- Device
- Curetis Unyvero LRT Application
- Applicant
- Curetis GmbH
- 510(k) number
- DEN170047
- Product code
- QBH
- Decision
- Unknown (DENG)
- Decision date
- 2018-04-03
- Date received
- 2017-09-11
- Regulation
- 866.3985
- Classification name
- Lower Respiratory Microbial Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Gail E. Radcliffe
- Address
- Max-Eyth Strabe 42 Holzgerlingen DE 71088 71088
FDA Registration Numbers#
- 3010749841
- 3004613294
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QBH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191967 | Unyvero LRT BAL Application | Curetis GmbH | 2019-12-20 |