The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Cholesterol-incorporating Dynamic Stab Tech (dst).
| Device ID | K962890 |
| 510k Number | K962890 |
| Device Name: | CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | TRACE SCIENTIFIC LTD. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston TRACE SCIENTIFIC LTD. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-24 |
| Decision Date | 1996-09-27 |