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510(k) K191967

Device
Unyvero LRT BAL Application
Applicant
Curetis GmbH
510(k) number
K191967
Product code
QBH  
Decision
Substantially Equivalent (SESE)
Decision date
2019-12-20
Date received
2019-07-23
Regulation
866.3985
Classification name
Lower Respiratory Microbial Nucleic Acid Detection System
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Karsten Mueller
Address
Max-Eyth-Straße 42 Holzgerlingen DE 71088 71088

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QBH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
DEN170047Curetis Unyvero LRT ApplicationCuretis GmbH2018-04-03

Legacy Summary#

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FDA Review#

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