The following data is part of a premarket notification filed by Vital Diagnostics (manufacturing) Pty Ltd with the FDA for Eon 100 Chemistry Analyzer With Ise , Model 77105, Bicarbonate Reagent, Model 77475.
| Device ID | K100060 |
| 510k Number | K100060 |
| Device Name: | EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 |
| Classification | Enzymatic, Carbon-dioxide |
| 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 | KHS |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CIX |
| Subsequent Product Code | JFJ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJE |
| Subsequent Product Code | KNK |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-11 |
| Decision Date | 2010-12-15 |