GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION

Hexokinase, Glucose

HERAEUS KULZER, INC.

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

Pre-market Notification Details

Device IDK951058
510k NumberK951058
Device Name:GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION
ClassificationHexokinase, 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 CodeCFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-07
Decision Date1995-06-01

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