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510(k) K200129

Device
OncoMate MSI Dx Analysis System
Applicant
Promega Corporation
510(k) number
K200129
Product code
PZJ  
Decision
Substantially Equivalent (SESE)
Decision date
2021-07-26
Date received
2020-01-21
Regulation
864.1866
Classification name
Lynch Syndrome Test System
Medical specialty
Immunology
Review panel
Pathology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ron Wheeler
Address
2800 Woods Hollow Rd. Madison WI US 53711 53711

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PZJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K211181Idylla MSI TestBiocartis NV2023-02-27
K213348BOND MMR Antibody PanelLeica Biosystems Newcastle, Ltd.2023-02-21
DEN170030VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary AntibodyVentana Medical Systems2017-10-27

Legacy Summary#

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FDA Review#

Decision Summary