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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitroprusside, Ketones (Urinary, Non-Quant.)
510(k) Number K911801
Device Name KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON
Applicant
Gds Technology, LLC
25235 Leer Dr.
P.O. Box 473
Elkhart,  IN  46515
Applicant Contact DE CASTRO
Correspondent
Gds Technology, LLC
25235 Leer Dr.
P.O. Box 473
Elkhart,  IN  46515
Correspondent Contact DE CASTRO
Regulation Number862.1435
Classification Product Code
JIN  
Date Received04/23/1991
Decision Date 07/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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