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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Whole Blood Hemoglobin Determination
510(k) Number K973649
Device Name HEMOSITE TEST SYSTEM
Applicant
Gds Technology, LLC
25235 Leer Dr.
Elkhart,  IN  46514
Applicant Contact JONATHAN A KOVACH
Correspondent
Gds Technology, LLC
25235 Leer Dr.
Elkhart,  IN  46514
Correspondent Contact JONATHAN A KOVACH
Regulation Number864.7500
Classification Product Code
KHG  
Date Received09/25/1997
Decision Date 08/31/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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