The following data is part of a premarket notification filed by Sterling Diagnostics, Inc. with the FDA for Triglycerides Reagent Set.
Device ID | K914609 |
510k Number | K914609 |
Device Name: | TRIGLYCERIDES REAGENT SET |
Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
Applicant | STERLING DIAGNOSTICS, INC. 6226 PRODUCT DR. Sterling Heights, MI 48312 |
Contact | David L Callender |
Correspondent | David L Callender STERLING DIAGNOSTICS, INC. 6226 PRODUCT DR. Sterling Heights, MI 48312 |
Product Code | CDT |
CFR Regulation Number | 862.1705 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-17 |
Decision Date | 1991-11-07 |