The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Magnesium Assay Kit, Cat.# 100-12.
| Device ID | K912825 |
| 510k Number | K912825 |
| Device Name: | MAGNESIUM ASSAY KIT, CAT.# 100-12 |
| Classification | Photometric Method, Magnesium |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Product Code | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-26 |
| Decision Date | 1991-07-26 |