The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Magnesium Assay (xb), Models 125-12, 125-50 And 125-s7.
| Device ID | K063208 |
| 510k Number | K063208 |
| Device Name: | MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 |
| Classification | Photometric Method, Magnesium |
| Applicant | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, P.e.i., CA C1e 2a6 |
| Contact | Debbie M Murray |
| Correspondent | Debbie M Murray DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown, P.e.i., CA C1e 2a6 |
| Product Code | JGJ |
| CFR Regulation Number | 862.1495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-23 |
| Decision Date | 2007-01-19 |