ENZYMATIC CHOLESTEROL (COLORIMETRIC

Enzymatic Esterase--oxidase, Cholesterol

ANALYTICAL & RESEARCH CHEMICALS, INC.

The following data is part of a premarket notification filed by Analytical & Research Chemicals, Inc. with the FDA for Enzymatic Cholesterol (colorimetric.

Pre-market Notification Details

Device IDK823784
510k NumberK823784
Device Name:ENZYMATIC CHOLESTEROL (COLORIMETRIC
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant ANALYTICAL & RESEARCH CHEMICALS, 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 Received1982-12-16
Decision Date1983-01-14

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