Product code CGO
- Device name
- Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1175
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K850938 | CHOLESTEROL | Dilab, Inc. | 1985-06-25 |
| K811747 | KING DIAGNOSTICS CHOLESTEROL TEST | King Diagnostics, Inc. | 1981-07-10 |
| K810090 | CHOLESTEROL REAGENT | Anco Medical Reagents & Assoc. | 1981-01-26 |
| K800682 | REAGENTS FOR DETERM. CHOLESTEROL/SERUM | Diagnostic Solutions, Inc. | 1980-05-28 |
| K781611 | CHOLESTEROL DET. IN SERUM | Fisher Scientific Co., LLC | 1978-10-24 |
| K780545 | SR-PLUS DIRECT CHOLESTEROL TEST | Stanbio Laboratory | 1978-05-26 |
| K772043 | ALPHA/CHOL | Standard Scientific, Inc. | 1977-11-28 |
| K771833 | CHOLESTEROL | Gamma Enterprises, Inc. | 1977-10-18 |
| K771313 | CHOLESTEROL REAGENT | Mallinckrodt Critical Care | 1977-08-03 |
| K771093 | UNIPAK CHOLESTEROL | Harleco | 1977-07-21 |
| K770457 | CHOLESTEROL PROCEDURE, TEKPOINT TOTAL | Icn Pharmaceuticals, Inc. | 1977-05-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06971674860105 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860198 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860181 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860174 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860167 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860150 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860143 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860136 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860129 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860112 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860013 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860099 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860082 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860075 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860068 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860051 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860044 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860037 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |
| 06971674860020 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-08 |