The following data is part of a premarket notification filed by Simmler & Son, Inc. with the FDA for Glycerol Kinase.
Device ID | K771904 |
510k Number | K771904 |
Device Name: | GLYCEROL KINASE |
Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
Applicant | SIMMLER & SON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CDT |
CFR Regulation Number | 862.1705 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-07 |
Decision Date | 1977-12-06 |