The following data is part of a premarket notification filed by Vital Diagnostics (manufacturing) Pty. Ltd. with the FDA for Vital Serum Controls.
| Device ID | K111063 |
| 510k Number | K111063 |
| Device Name: | VITAL SERUM CONTROLS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | VITAL DIAGNOSTICS (MANUFACTURING) PTY. LTD. 189-190 BROWNS ROAD Noble Park Victoria, AT 3174 |
| Contact | Melita Lambiris |
| Correspondent | Melita Lambiris VITAL DIAGNOSTICS (MANUFACTURING) PTY. LTD. 189-190 BROWNS ROAD Noble Park Victoria, AT 3174 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-18 |
| Decision Date | 2011-06-28 |