Cholesterol
FDA 510(k) K850938 · Dilab, Inc.
510(k) numberK850938
Submission
- Device name
- Cholesterol
- Applicant
- Dilab, Inc.
Miami, FL, US - Received
- March 7, 1985
- Decision date
- June 25, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CGO – Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CGO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K811747 | King Diagnostics Cholesterol TestCGO · Traditional | King Diagnostics, Inc. | 07/10/1981SE |
| K810090 | Cholesterol ReagentCGO · Traditional | Anco Medical Reagents & Assoc. | 01/26/1981SE |
| K800682 | Reagents for Determ. Cholesterol/SerumCGO · Traditional | Diagnostic Solutions, Inc. | 05/28/1980SE |
| K781611 | Cholesterol Det. in SerumCGO · Traditional | Fisher Scientific Co., LLC | 10/24/1978SE |
| K780545 | Sr-Plus Direct Cholesterol TestCGO · Traditional | Stanbio Laboratory | 05/26/1978SE |
| K772043 | Alpha/CholCGO · Traditional | Standard Scientific, Inc. | 11/28/1977SE |
| K771833 | CholesterolCGO · Traditional | Gamma Enterprises, Inc. | 10/18/1977SE |
| K771313 | Cholesterol ReagentCGO · Traditional | Mallinckrodt Critical Care | 08/03/1977SE |
| K771093 | Unipak CholesterolCGO · Traditional | Harleco | 07/21/1977SE |
| K770457 | Cholesterol Procedure, Tekpoint TotalCGO · Traditional | Icn Pharmaceuticals, Inc. | 05/03/1977SE |
More from Icn Pharmaceuticals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K862530 | Rapid AS LatexGTQ · Traditional | 04/21/1987SE |
| K850931 | AlbuminCIX · Traditional | 06/26/1985SE |
| K850936 | Total ProteinsCEK · Traditional | 06/25/1985SE |
| K850934 | PhosphorusCEO · Traditional | 06/25/1985SE |
| K850933 | Uric AcidCDH · Traditional | 06/25/1985SE |
| K850932 | CreatinineCGX · Traditional | 06/25/1985SE |
| K850937 | UreaCDW · Traditional | 06/10/1985SE |
| K850935 | ChlorideCHJ · Traditional | 06/10/1985SE |
| K850930 | GlucoseCGE · Traditional | 06/10/1985SE |
| K850929 | CalciumCIC · Traditional | 06/10/1985SE |
Questions and answers
When was Cholesterol cleared by the FDA?
Cholesterol (K850938) received a 510(k) decision of Substantially Equivalent on June 25, 1985, 110 days after the submission was received.
What is the product code of K850938?
The FDA product code is CGO – Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.