Device Classification Name |
Lynch Syndrome Test System
|
510(k) Number |
K200129 |
Device Name |
OncoMate MSI Dx Analysis System |
Applicant |
Promega Corporation |
2800 Woods Hollow Rd |
Madison,
WI
53711
|
|
Applicant Contact |
Ron Wheeler |
Correspondent |
Promega Corporation |
2800 Woods Hollow Rd |
Madison,
WI
53711
|
|
Correspondent Contact |
Pamela Swatkowski |
Regulation Number | 864.1866
|
Classification Product Code |
|
Date Received | 01/21/2020 |
Decision Date | 07/26/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|