The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Triglycerides Determination.
Device ID | K871122 |
510k Number | K871122 |
Device Name: | TRIGLYCERIDES DETERMINATION |
Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
Applicant | BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami, FL 33152 |
Contact | Alejo V Roy |
Correspondent | Alejo V Roy BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami, FL 33152 |
Product Code | CDT |
CFR Regulation Number | 862.1705 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-20 |
Decision Date | 1987-04-07 |