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CGO — Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol Class I

FDA Device Classification

Classification Details

Product Code
CGO
Device Class
Class I
Regulation Number
862.1175
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K850938dilabCHOLESTEROLJune 25, 1985
K811747king diagnosticsKING DIAGNOSTICS CHOLESTEROL TESTJuly 10, 1981
K810090anco medical reagents and assocCHOLESTEROL REAGENTJanuary 26, 1981
K800682diagnostic solutionsREAGENTS FOR DETERM. CHOLESTEROL/SERUMMay 28, 1980
K781611fisher scientific coCHOLESTEROL DET. IN SERUMOctober 24, 1978
K780545stanbio laboratorySR-PLUS DIRECT CHOLESTEROL TESTMay 26, 1978
K772043standard scientificALPHA/CHOLNovember 28, 1977
K771833gamma enterprisesCHOLESTEROLOctober 18, 1977
K771313mallinckrodt critical careCHOLESTEROL REAGENTAugust 3, 1977
K771093harlecoUNIPAK CHOLESTEROLJuly 21, 1977
K770457icn pharmaceuticalsCHOLESTEROL PROCEDURE, TEKPOINT TOTALMay 3, 1977