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 |