Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
The Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol test system (product code CGO) is an in-vitro diagnostic device used in clinical chemistry to measure total cholesterol in serum or plasma using the Lieberman-Burchard or Abell-Kendall colorimetric reference methods. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1175 in the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- CGO
- Device Class
- FDA class 1
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K850938 | CHOLESTEROL | Jun 25, 1985 | Substantially Equivalent | Dilab, Inc. |
| K811747 | KING DIAGNOSTICS CHOLESTEROL TEST | Jul 10, 1981 | Substantially Equivalent | King Diagnostics, Inc. |
| K810090 | CHOLESTEROL REAGENT | Jan 26, 1981 | Substantially Equivalent | Anco Medical Reagents & Assoc. |
| K800682 | REAGENTS FOR DETERM. CHOLESTEROL/SERUM | May 28, 1980 | Substantially Equivalent | Diagnostic Solutions, Inc. |
| K781611 | CHOLESTEROL DET. IN SERUM | Oct 24, 1978 | Substantially Equivalent | Fisher Scientific Co., LLC |
| K780545 | SR-PLUS DIRECT CHOLESTEROL TEST | May 26, 1978 | Substantially Equivalent | Stanbio Laboratory |
| K772043 | ALPHA/CHOL | Nov 28, 1977 | Substantially Equivalent | Standard Scientific, Inc. |
| K771833 | CHOLESTEROL | Oct 18, 1977 | Substantially Equivalent | Gamma Enterprises, Inc. |
| K771313 | CHOLESTEROL REAGENT | Aug 03, 1977 | Substantially Equivalent | Mallinckrodt Critical Care |
| K771093 | UNIPAK CHOLESTEROL | Jul 21, 1977 | Substantially Equivalent | Harleco |
| K770457 | CHOLESTEROL PROCEDURE, TEKPOINT TOTAL | May 03, 1977 | Substantially Equivalent | Icn Pharmaceuticals, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.