The following data is part of a premarket notification filed by Harleco with the FDA for Ultrachem Enzymatic Cholesterol 65025.
| Device ID | K780523 |
| 510k Number | K780523 |
| Device Name: | ULTRACHEM ENZYMATIC CHOLESTEROL 65025 |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-31 |
| Decision Date | 1978-05-19 |