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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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