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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation
510(k) Number K902614
Device Name ELVI 828 DIGICLOT MULTISCAN
Applicant
Logos Scientific, Inc.
700 Sunset Rd.
Henderson,  NV  89015
Applicant Contact EJ BECHTEL
Correspondent
Logos Scientific, Inc.
700 Sunset Rd.
Henderson,  NV  89015
Correspondent Contact EJ BECHTEL
Regulation Number864.5400
Classification Product Code
KQG  
Date Received06/13/1990
Decision Date 11/08/1990
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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