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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 K971145
Device Name GLUCOSITE TEST SYSTEM
Applicant
Gds Technology, LLC
25235 Leer Dr.
Elkhart,  IN  46514
Applicant Contact JOHN W SWATOSH
Correspondent
Gds Technology, LLC
25235 Leer Dr.
Elkhart,  IN  46514
Correspondent Contact JOHN W SWATOSH
Regulation Number862.1345
Classification Product Code
CGA  
Date Received03/28/1997
Decision Date 09/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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