The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Enzymatic Cholesterol Reagent (single Vial).
| Device ID | K860717 |
| 510k Number | K860717 |
| Device Name: | ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL) |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Contact | Riddle |
| Correspondent | Riddle 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 | 1986-02-26 |
| Decision Date | 1986-04-11 |