The following data is part of a premarket notification filed by Abbott Ireland Diagnostics Division with the FDA for Cholesterol2.
| Device ID | K203597 |
| 510k Number | K203597 |
| Device Name: | Cholesterol2 |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | Abbott Ireland Diagnostics Division Lisnamuck Longford, IE |
| Contact | Tracy Schmidt |
| Correspondent | Tracy Schmidt Abbott Ireland Diagnostics Division Lisnamuck Longford, IE |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-09 |
| Decision Date | 2022-06-30 |