LINEAR ENZYMATIC CHOLESTEROL SYSTEM

Enzymatic Esterase--oxidase, Cholesterol

SIMMLER, INC.

The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Linear Enzymatic Cholesterol System.

Pre-market Notification Details

Device IDK800199
510k NumberK800199
Device Name:LINEAR ENZYMATIC CHOLESTEROL SYSTEM
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant SIMMLER, INC. 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 Received1980-01-30
Decision Date1980-02-21

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