TRILOGY ANALYZER

Glucose Oxidase, Glucose

DREW SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Drew Scientific, Inc. with the FDA for Trilogy Analyzer.

Pre-market Notification Details

Device IDK070704
510k NumberK070704
Device Name:TRILOGY ANALYZER
ClassificationGlucose Oxidase, Glucose
Applicant DREW SCIENTIFIC, INC. 49 PLAIN ST. North Attleboro,  MA  02760
ContactCynthia Sinclair
CorrespondentCynthia Sinclair
DREW SCIENTIFIC, INC. 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeCGA  
Subsequent Product CodeCDQ
Subsequent Product CodeCEM
Subsequent Product CodeCGX
Subsequent Product CodeCGZ
Subsequent Product CodeJGS
Subsequent Product CodeJJE
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-13
Decision Date2007-07-13
Summary:summary

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