The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Triglyceride Diagnostic Kit.
| Device ID | K830288 |
| 510k Number | K830288 |
| Device Name: | TRIGLYCERIDE DIAGNOSTIC KIT |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-27 |
| Decision Date | 1983-02-25 |