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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, multipurpose for in vitro coagulation studies
510(k) Number K791586
Device Name ELVI 818 DIGICLOT MULTISCAN
Original Applicant
VOLU SOL MEDICAL INDUSTRIES
Regulation Number864.5425
Classification Product Code
JPA  
Date Received08/17/1979
Decision Date 09/17/1979
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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