GLUCOFILM TEST STRIPS

Glucose Oxidase, Glucose

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Glucofilm Test Strips.

Pre-market Notification Details

Device IDK926360
510k NumberK926360
Device Name:GLUCOFILM TEST STRIPS
ClassificationGlucose Oxidase, Glucose
Applicant HERAEUS KULZER, INC. P.O. BOX 2004 Mishawaka,  IN  46546 -2004
ContactRosanne M Savol
CorrespondentRosanne M Savol
HERAEUS KULZER, INC. P.O. BOX 2004 Mishawaka,  IN  46546 -2004
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-21
Decision Date1993-09-08

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