The following data is part of a premarket notification filed by Biomed Diagnostics Incorporated with the FDA for Intray Gc.
| Device ID | K210511 |
| 510k Number | K210511 |
| Device Name: | InTray GC |
| Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
| Applicant | Biomed Diagnostics Incorporated 1388 Antelope Road White City, OR 97503 |
| Contact | John F Antiabong |
| Correspondent | John F Antiabong Biomed Diagnostics Incorporated 1388 Antelope Road White City, OR 97503 |
| Product Code | JTY |
| CFR Regulation Number | 866.2410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-23 |
| Decision Date | 2021-10-20 |