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510(k) K190613

Device
BD MAX Check-Points CPO
Applicant
Check-Points Health B.V.
510(k) number
K190613
Product code
POC  
Decision
Substantially Equivalent (SESE)
Decision date
2019-08-29
Date received
2019-03-11
Regulation
866.1640
Classification name
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Pieter Vos
Address
Binnenhaven 5 Wageningen NL 6709 6709

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code POC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K173263Xpert Carba-RCepheid2018-01-09
K160901Xpert Carba-RCepheid2016-06-29

Legacy Summary#

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FDA Review#

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