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 |