The following data is part of a premarket notification filed by Gamma Enterprises, Inc. with the FDA for Cholesterol.
Device ID | K771833 |
510k Number | K771833 |
Device Name: | CHOLESTEROL |
Classification | Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol |
Applicant | GAMMA ENTERPRISES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CGO |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-09-21 |
Decision Date | 1977-10-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CHOLESTEROL 73837165 1611220 Dead/Cancelled |
KSF MEDICAL PUBLISHING COMPANY, INC. 1989-11-09 |
CHOLESTEROL 73783518 not registered Dead/Abandoned |
DAWN FOOD PRODUCTS, INC. 1989-02-27 |