The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Triglyceride's Test (trigli-cinet).
| Device ID | K854783 |
| 510k Number | K854783 |
| Device Name: | TRIGLYCERIDE'S TEST (TRIGLI-CINET) |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Contact | Debra Hofmeister |
| Correspondent | Debra Hofmeister SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-29 |
| Decision Date | 1986-01-22 |