The following data is part of a premarket notification filed by Trace America, Inc. with the FDA for Urea (urea Nitrogen) - Incorporating Dynamic Stabilization Technology (dst).
| Device ID | K971477 |
| 510k Number | K971477 |
| Device Name: | UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| 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 | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-23 |
| Decision Date | 1997-05-27 |