The following data is part of a premarket notification filed by Analytical & Research Chemicals, Inc. with the FDA for Enzymatic Cholesterol (colorimetric.
Device ID | K823784 |
510k Number | K823784 |
Device Name: | ENZYMATIC CHOLESTEROL (COLORIMETRIC |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
Applicant | ANALYTICAL & RESEARCH CHEMICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CHH |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-16 |
Decision Date | 1983-01-14 |