CGO · Class I · 21 CFR 862.1175

FDA Product Code CGO: Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol

Leading manufacturers include Diagnostic Solutions, Inc., Anco Medical Reagents & Assoc. and King Diagnostics, Inc..

11
Total
11
Cleared
42d
Avg days
1977
Since

FDA 510(k) Cleared Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol Devices (Product Code CGO)

11 devices
1–11 of 11
Cleared Jul 10, 1981
KING DIAGNOSTICS CHOLESTEROL TEST
K811747
King Diagnostics, Inc.
Chemistry · 18d
Cleared Jan 26, 1981
CHOLESTEROL REAGENT
K810090
Anco Medical Reagents & Assoc.
Chemistry · 13d
Cleared May 28, 1980
REAGENTS FOR DETERM. CHOLESTEROL/SERUM
K800682
Diagnostic Solutions, Inc.
Chemistry · 63d
Cleared Oct 24, 1978
CHOLESTEROL DET. IN SERUM
K781611
Fisher Scientific Co., LLC
Chemistry · 35d
Cleared May 26, 1978
SR-PLUS DIRECT CHOLESTEROL TEST
K780545
Stanbio Laboratory
Chemistry · 53d
Cleared Oct 18, 1977
CHOLESTEROL
K771833
Gamma Enterprises, Inc.
Chemistry · 27d
Cleared Aug 03, 1977
CHOLESTEROL REAGENT
K771313
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Jul 21, 1977
UNIPAK CHOLESTEROL
K771093
Harleco
Chemistry · 35d
Cleared May 03, 1977
CHOLESTEROL PROCEDURE, TEKPOINT TOTAL
K770457
Icn Pharmaceuticals, Inc.
Chemistry · 56d

About Product Code CGO - Regulatory Context