The following data is part of a premarket notification filed by Alta Diagnostics, Inc. with the FDA for Magnesium Reagent.
| Device ID | K800327 |
| 510k Number | K800327 |
| Device Name: | MAGNESIUM REAGENT |
| Classification | Photometric Method, Magnesium |
| Applicant | ALTA DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-12 |
| Decision Date | 1980-03-25 |