CHOLESTEROL TEST SYSTEM

Enzymatic Esterase--oxidase, Cholesterol

HANS J. BROUWERS & ASSOC.

The following data is part of a premarket notification filed by Hans J. Brouwers & Assoc. with the FDA for Cholesterol Test System.

Pre-market Notification Details

Device IDK850390
510k NumberK850390
Device Name:CHOLESTEROL TEST SYSTEM
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant HANS J. BROUWERS & ASSOC. P.O. BOX 823 Mount Prospect,  IL  60056
ContactHans J Brouwers
CorrespondentHans J Brouwers
HANS J. BROUWERS & ASSOC. P.O. BOX 823 Mount Prospect,  IL  60056
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-01
Decision Date1985-07-09

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