The following data is part of a premarket notification filed by Vital Diagnostics (manufacturing) Pty Ltd with the FDA for Atac Serum Calibrator (direct Bilirubin And Iron).
| Device ID | K110394 |
| 510k Number | K110394 |
| Device Name: | ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD 189-199 BROWNS RD Noble Park, Victoria, AU 3174 |
| Contact | Melita Lambiris |
| Correspondent | Melita Lambiris VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD 189-199 BROWNS RD Noble Park, Victoria, AU 3174 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-11 |
| Decision Date | 2011-06-09 |