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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Russel Viper Venom
510(k) Number K903037
Device Name LUPO-TEST REAGENT
Applicant
Gradipore , Ltd.
200 Harris St.
P.O. Box 65
Pyrmont,  AU NSW 2009
Applicant Contact RHONDA SMYTH
Correspondent
Gradipore , Ltd.
200 Harris St.
P.O. Box 65
Pyrmont,  AU NSW 2009
Correspondent Contact RHONDA SMYTH
Regulation Number864.8950
Classification Product Code
GIR  
Date Received07/11/1990
Decision Date 12/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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