The following data is part of a premarket notification filed by Vital Diagnostics Pty. Ltd with the FDA for Eon Cholesterol Reagent.
| Device ID | K120202 |
| 510k Number | K120202 |
| Device Name: | EON CHOLESTEROL REAGENT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | VITAL DIAGNOSTICS PTY. LTD 189 - 199 BROWNS ROAD Noble Park, Victoria, AU 3174 |
| Contact | Melita Lambiris |
| Correspondent | Melita Lambiris VITAL DIAGNOSTICS PTY. LTD 189 - 199 BROWNS ROAD Noble Park, Victoria, AU 3174 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-23 |
| Decision Date | 2012-07-27 |
| Summary: | summary |