The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Triglycerides Reagent Gpo 5 X Conc..
| Device ID | K903897 |
| 510k Number | K903897 |
| Device Name: | TRIGLYCERIDES REAGENT GPO 5 X CONC. |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | TRACE SCIENTIFIC LTD. P.O. BOX 310 Clayton, Australia 3168, AU 3168 |
| Contact | Peter Murphy |
| Correspondent | Peter Murphy TRACE SCIENTIFIC LTD. P.O. BOX 310 Clayton, Australia 3168, AU 3168 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-23 |
| Decision Date | 1990-10-01 |