ULTRACHEM GLUC-DH

Glucose Dehydrogenase, Glucose

HARLECO DIAGNOSTICS

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

Pre-market Notification Details

Device IDK821867
510k NumberK821867
Device Name:ULTRACHEM GLUC-DH
ClassificationGlucose Dehydrogenase, Glucose
Applicant HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-25
Decision Date1982-07-06

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