CGOClass I
Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
21 CFR 862.1175 / Clinical Chemistry
CGO is the FDA product code for Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol, a class I device type, regulated under 21 CFR 862.1175. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- CGO
- Device name
- Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
- Regulation
- 21 CFR 862.1175
- Device class
- Class I
- Review panel
- Clinical Chemistry
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 11
- Ingested recalls
- 0
Clearances, product code CGO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 5 |
| 1978 | 2 |
| 1980 | 1 |
| 1981 | 2 |
| 1985 | 1 |
Applicants with the most clearances
Product code CGO| Applicant | Clearances |
|---|---|
| Anco Medical Reagents & Assoc. | 1 |
| Diagnostic Solutions, Inc. | 1 |
| Dilab, Inc. | 1 |
| Fisher Scientific Company L.L.C. | 1 |
| Gamma Enterprises, Inc. | 1 |
| Harleco | 1 |
| Icn Pharmaceuticals, Inc. | 1 |
| King Diagnostics, Inc. | 1 |
| Mallinckrodt Critical Care | 1 |
| Stanbio Laboratory | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
