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510(k) K160901

Device
Xpert Carba-R
Applicant
CEPHEID
510(k) number
K160901
Product code
POC  
Decision
Substantially Equivalent (SESE)
Decision date
2016-06-29
Date received
2016-04-01
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
SCOTT A. CAMPBELL
Address
904 Caribbean Dr. Sunnyvale CA US 94089 94089

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
K190613BD MAX Check-Points CPOCheck-Points Health B.V.2019-08-29
K173263Xpert Carba-RCepheid2018-01-09

Legacy Summary#

summary

FDA Review#

Decision Summary