LYPOPROTEIN CHOLESTEROL TEST KIT

Colorimetric Method, Lipoproteins

ENVIRONMENTAL CHEMICAL SPECIALTIES

The following data is part of a premarket notification filed by Environmental Chemical Specialties with the FDA for Lypoprotein Cholesterol Test Kit.

Pre-market Notification Details

Device IDK780173
510k NumberK780173
Device Name:LYPOPROTEIN CHOLESTEROL TEST KIT
ClassificationColorimetric Method, Lipoproteins
Applicant ENVIRONMENTAL CHEMICAL SPECIALTIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHM  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-02-02
Decision Date1978-05-03

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