DURAZYME CHOLESTEROL

Enzymatic Esterase--oxidase, Cholesterol

AMERICAN MONITOR CORP.

The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Durazyme Cholesterol.

Pre-market Notification Details

Device IDK840368
510k NumberK840368
Device Name:DURAZYME CHOLESTEROL
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant AMERICAN MONITOR CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-27
Decision Date1984-03-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.