The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Lipase Hydrolysis/glycerol Kinase, Triglycerides.
Device ID | K863874 |
510k Number | K863874 |
Device Name: | LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES |
Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
Contact | Labrec, Ph.d. |
Correspondent | Labrec, Ph.d. ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
Product Code | CDT |
CFR Regulation Number | 862.1705 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-03 |
Decision Date | 1986-11-13 |