CGO — Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol Class I
FDA product code CGO covers "Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol", a Class I medical device regulated under 21 CFR 862.1175. Submissions are reviewed by the Clinical Chemistry panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CGO
- Device Class
- Class I
- Regulation Number
- 862.1175
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K850938 | dilab | CHOLESTEROL | June 25, 1985 |
| K811747 | king diagnostics | KING DIAGNOSTICS CHOLESTEROL TEST | July 10, 1981 |
| K810090 | anco medical reagents and assoc | CHOLESTEROL REAGENT | January 26, 1981 |
| K800682 | diagnostic solutions | REAGENTS FOR DETERM. CHOLESTEROL/SERUM | May 28, 1980 |
| K781611 | fisher scientific co | CHOLESTEROL DET. IN SERUM | October 24, 1978 |
| K780545 | stanbio laboratory | SR-PLUS DIRECT CHOLESTEROL TEST | May 26, 1978 |
| K772043 | standard scientific | ALPHA/CHOL | November 28, 1977 |
| K771833 | gamma enterprises | CHOLESTEROL | October 18, 1977 |
| K771313 | mallinckrodt critical care | CHOLESTEROL REAGENT | August 3, 1977 |
| K771093 | harleco | UNIPAK CHOLESTEROL | July 21, 1977 |
| K770457 | icn pharmaceuticals | CHOLESTEROL PROCEDURE, TEKPOINT TOTAL | May 3, 1977 |