The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Liquid Stable Triglycerides Reagent Set.
| Device ID | K834518 |
| 510k Number | K834518 |
| Device Name: | LIQUID STABLE TRIGLYCERIDES REAGENT SET |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-21 |
| Decision Date | 1984-03-02 |