The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Multichem Enzymatic Cholesterol Sys.
| Device ID | K831700 |
| 510k Number | K831700 |
| Device Name: | MULTICHEM ENZYMATIC CHOLESTEROL SYS |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | SIMMLER, INC. 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 | 1983-05-24 |
| Decision Date | 1983-07-19 |