ULTRACHEM TRI-ES

Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

HARLECO DIAGNOSTICS

The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Ultrachem Tri-es.

Pre-market Notification Details

Device IDK821875
510k NumberK821875
Device Name:ULTRACHEM TRI-ES
ClassificationLipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Applicant HARLECO DIAGNOSTICS 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 Received1982-06-25
Decision Date1982-07-13

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