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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 K994073
Device Name HEMOSITE TEST SYSTEM
Applicant
Gds Technology, LLC
25235 Leer Dr.
P.O. Box 473
Elkhart,  IN  46515
Applicant Contact KEITH CRAWFORD
Correspondent
Gds Technology, LLC
25235 Leer Dr.
P.O. Box 473
Elkhart,  IN  46515
Correspondent Contact KEITH CRAWFORD
Regulation Number864.7500
Classification Product Code
KHG  
Date Received12/02/1999
Decision Date 01/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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