Unyvero LRT BAL Application— 510(k) K191967
Substantially EquivalentCuretis GmbH
FDA 510(k) clearance K191967 for Unyvero LRT BAL Application, Substantially Equivalent on 2019-12-20. Applicant: Curetis GmbH. Device class: 2.
Clearance details
- Applicant
- Curetis GmbH
- Product code
- Code QBH
- Device class
- Class 2
- Regulation
- 21 CFR 866.3985
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Holzgerlingen, DE
Recent devices under product code QBH
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