FDA 510(k) Applications for Medical Device Product Code "CGO"
(Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol)

FDA 510(k) Number Applicant Device Name Decision Date
K810090 ANCO MEDICAL REAGENTS & ASSOC. CHOLESTEROL REAGENT 01/26/1981
K800682 DIAGNOSTIC SOLUTIONS, INC. REAGENTS FOR DETERM. CHOLESTEROL/SERUM 05/28/1980
K850938 DILAB, INC. CHOLESTEROL 06/25/1985
K781611 FISHER SCIENTIFIC CO., LLC. CHOLESTEROL DET. IN SERUM 10/24/1978
K771833 GAMMA ENTERPRISES, INC. CHOLESTEROL 10/18/1977
K771093 HARLECO UNIPAK CHOLESTEROL 07/21/1977
K770457 ICN PHARMACEUTICALS, INC. CHOLESTEROL PROCEDURE, TEKPOINT TOTAL 05/03/1977
K811747 KING DIAGNOSTICS, INC. KING DIAGNOSTICS CHOLESTEROL TEST 07/10/1981
K771313 MALLINCKRODT CRITICAL CARE CHOLESTEROL REAGENT 08/03/1977
K780545 STANBIO LABORATORY SR-PLUS DIRECT CHOLESTEROL TEST 05/26/1978
K772043 STANDARD SCIENTIFIC, INC. ALPHA/CHOL 11/28/1977


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