TRIGLYCERIDE DIAGNOSTIC KIT

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Triglyceride Diagnostic Kit.

Pre-market Notification Details

Device IDK830288
510k NumberK830288
Device Name:TRIGLYCERIDE DIAGNOSTIC KIT
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDT  
CFR Regulation Number862.1705 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-01-27
Decision Date1983-02-25

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