CHOLESTEROL TEST

Enzymatic Esterase--oxidase, Cholesterol

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Cholesterol Test.

Pre-market Notification Details

Device IDK770265
510k NumberK770265
Device Name:CHOLESTEROL TEST
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant SCLAVO, 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 Received1977-02-11
Decision Date1977-02-25

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