The following data is part of a premarket notification filed by Trace America, Inc. with the FDA for Trace Hdl Cholesterol - Automated (homogen.
| Device ID | K962723 |
| 510k Number | K962723 |
| Device Name: | TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN |
| Classification | Ldl & Vldl Precipitation, Hdl |
| 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 | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-15 |
| Decision Date | 1997-03-13 |