The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Resubmitted Triglyceride Gpo Reagent (single Vial).
| Device ID | K871509 |
| 510k Number | K871509 |
| Device Name: | RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Contact | William C Riddle |
| Correspondent | William C Riddle TRACE SCIENTIFIC LTD. 10 TREFOREST DR. Clayton, Vic 3168, AU |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-16 |
| Decision Date | 1987-05-08 |