CHH · Class I · 21 CFR 862.1175

FDA Product Code CHH: Enzymatic Esterase--oxidase, Cholesterol

Leading manufacturers include Em Diagnostic Systems, Inc., Beckman Instruments, Inc. and Boehringer Mannheim Corp..

230
Total
230
Cleared
87d
Avg days
1976
Since
230 devices
49–72 of 230
Cleared Sep 13, 1977
HOLESTEROL DELTA TEST ASSAY
K771582
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 26d
Cleared Jan 26, 1977
GLUCOSE ANALYZER 2 W/ CHOLES. REAG KT
K761136
Beckman Instruments, Inc.
Chemistry · 63d
Cleared Jan 25, 1977
GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT
K761089
Beckman Instruments, Inc.
Chemistry · 64d