The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Liquid Stable Cholesterol Reagent Kit.
| Device ID | K902678 |
| 510k Number | K902678 |
| Device Name: | LIQUID STABLE CHOLESTEROL REAGENT KIT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Contact | Peter Murphy |
| Correspondent | Peter Murphy TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-19 |
| Decision Date | 1990-09-25 |