GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION

Glucose Oxidase, Glucose

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Glucometer Qa Blood Glucose Meter Modification.

Pre-market Notification Details

Device IDK934898
510k NumberK934898
Device Name:GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
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 Received1993-10-13
Decision Date1993-12-07

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