The following data is part of a premarket notification filed by Sterling Diagnostics, Inc. with the FDA for Enzynatic Triglycerides Reagent Set.
| Device ID | K855164 |
| 510k Number | K855164 |
| Device Name: | ENZYNATIC TRIGLYCERIDES REAGENT SET |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Contact | David Callender |
| Correspondent | David Callender STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights, MI 48077 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-26 |
| Decision Date | 1986-02-19 |