The following data is part of a premarket notification filed by Trace America, Inc. with the FDA for Triglycerides - Incorporating Dynamic Stabilization Technology.
| Device ID | K961477 |
| 510k Number | K961477 |
| Device Name: | TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-18 |
| Decision Date | 1996-08-05 |