The following data is part of a premarket notification filed by Mediatech, Inc. with the FDA for Glutamine-1-glutamine.
| Device ID | K850519 |
| 510k Number | K850519 |
| Device Name: | GLUTAMINE-1-GLUTAMINE |
| Classification | Media And Components, Synthetic Cell And Tissue Culture |
| Applicant | MEDIATECH, INC. EDWARD J. MILLER 1090 VERMONT AVE., NW #1200 Washington, DC 20005 |
| Contact | Hargrave, Dev |
| Correspondent | Hargrave, Dev MEDIATECH, INC. EDWARD J. MILLER 1090 VERMONT AVE., NW #1200 Washington, DC 20005 |
| Product Code | KIT |
| CFR Regulation Number | 864.2220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-08 |
| Decision Date | 1985-02-27 |