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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 K922326
Device Name LUPO-TEST REGEANT
Applicant
Graoipore , Ltd.
200 Harris St.
Sydney Nsw 2009, P.O. Box 65
Pyrmont 2009 Australia,  AU
Applicant Contact MANUSU
Correspondent
Graoipore , Ltd.
200 Harris St.
Sydney Nsw 2009, P.O. Box 65
Pyrmont 2009 Australia,  AU
Correspondent Contact MANUSU
Regulation Number864.8950
Classification Product Code
GIR  
Date Received05/11/1992
Decision Date 04/06/1993
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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