The following data is part of a premarket notification filed by Vital Diagnostics (manufacturing) Pty Ltd with the FDA for Eon Calcium Regent.
| Device ID | K120626 |
| 510k Number | K120626 |
| Device Name: | EON CALCIUM REGENT |
| Classification | Azo Dye, Calcium |
| Applicant | VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD 189-199 BROWNS RD Noble Park, AU 3174 |
| Contact | Melita Lambiris |
| Correspondent | Melita Lambiris VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD 189-199 BROWNS RD Noble Park, AU 3174 |
| Product Code | CJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-01 |
| Decision Date | 2012-08-22 |