ULTRACHEM E-GLU

Hexokinase, Glucose

HARLECO DIAGNOSTICS

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

Pre-market Notification Details

Device IDK821868
510k NumberK821868
Device Name:ULTRACHEM E-GLU
ClassificationHexokinase, Glucose
Applicant HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-25
Decision Date1982-07-08

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