ULTRACHEM GLUC-DH, #65048

Glucose Dehydrogenase, Glucose

EMD CHEMICALS INC.

The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Ultrachem Gluc-dh, #65048.

Pre-market Notification Details

Device IDK821463
510k NumberK821463
Device Name:ULTRACHEM GLUC-DH, #65048
ClassificationGlucose Dehydrogenase, Glucose
Applicant EMD CHEMICALS INC. 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 Received1982-05-18
Decision Date1982-06-02

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