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 |