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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 K990302
Device Name IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)
Applicant
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
LEXINGTON,  MA  02173
Applicant Contact CAROL MARBLE
Correspondent
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
LEXINGTON,  MA  02173
Correspondent Contact CAROL MARBLE
Regulation Number864.8950
Classification Product Code
GIR  
Date Received02/01/1999
Decision Date 04/08/1999
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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