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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K926362
Device Name GLUCOSTIX REAGENT STRIPS
Applicant
Heraeus Kulzer, Inc.
P.O. Box 2004
Mishawaka,  IN  46546 -2004
Applicant Contact ROSANNE M SAVOL
Correspondent
Heraeus Kulzer, Inc.
P.O. Box 2004
Mishawaka,  IN  46546 -2004
Correspondent Contact ROSANNE M SAVOL
Regulation Number862.1345
Classification Product Code
CGA  
Date Received12/21/1992
Decision Date 11/10/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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