ULTRACHEM E-CHOL, ITEM #65025

Enzymatic Esterase--oxidase, Cholesterol

HARLECO

The following data is part of a premarket notification filed by Harleco with the FDA for Ultrachem E-chol, Item #65025.

Pre-market Notification Details

Device IDK813039
510k NumberK813039
Device Name:ULTRACHEM E-CHOL, ITEM #65025
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant HARLECO 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 Received1981-10-28
Decision Date1981-11-10

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