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 |