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 |