The following data is part of a premarket notification filed by Promega Corporation with the FDA for Oncomate Msi Dx Analysis System.
| Device ID | K200129 |
| 510k Number | K200129 |
| Device Name: | OncoMate MSI Dx Analysis System |
| Classification | Lynch Syndrome Test System |
| Applicant | Promega Corporation 2800 Woods Hollow Rd Madison, WI 53711 |
| Contact | Ron Wheeler |
| Correspondent | Pamela Swatkowski Promega Corporation 2800 Woods Hollow Rd Madison, WI 53711 |
| Product Code | PZJ |
| CFR Regulation Number | 864.1866 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-21 |
| Decision Date | 2021-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849811031717 | K200129 | 000 |
| 00849811056864 | K200129 | 000 |
| 00849811056857 | K200129 | 000 |