The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Magnesium (magon).
| Device ID | K921677 |
| 510k Number | K921677 |
| Device Name: | BIOTROL MAGNESIUM (MAGON) |
| Classification | Photometric Method, Magnesium |
| Applicant | BIOTROL, USA, INC. 115 SUMMIT DR. Exton, PA 19341 |
| Contact | Allan C Murphy |
| Correspondent | Allan C Murphy BIOTROL, USA, INC. 115 SUMMIT DR. Exton, PA 19341 |
| Product Code | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-08 |
| Decision Date | 1992-05-26 |