The following data is part of a premarket notification filed by Cooper Biomedical, Inc. with the FDA for Demand Magnesium.
| Device ID | K851657 |
| 510k Number | K851657 |
| Device Name: | DEMAND MAGNESIUM |
| Classification | Photometric Method, Magnesium |
| Applicant | COOPER BIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Contact | Amiran Daniel |
| Correspondent | Amiran Daniel COOPER BIOMEDICAL, INC. ONE TECHNOLOGY COURT Malvern, PA 19355 |
| Product Code | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-23 |
| Decision Date | 1985-05-10 |