SET, TRINDER GLUCOSE

Glucose Oxidase, Glucose

PRINCETON BIOMEDIX

The following data is part of a premarket notification filed by Princeton Biomedix with the FDA for Set, Trinder Glucose.

Pre-market Notification Details

Device IDK760347
510k NumberK760347
Device Name:SET, TRINDER GLUCOSE
ClassificationGlucose Oxidase, Glucose
Applicant PRINCETON BIOMEDIX 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-08-02
Decision Date1976-10-05

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