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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 K851169
Device Name ELECTRA 800 AUTOMATIC COAGULATION TIMER
Applicant
Medical Laboratory Automation Systems, Inc.
500 Nuber Ave.
Mount Vernon,  NY  10550
Applicant Contact RICHARD E SCORDATO
Correspondent
Medical Laboratory Automation Systems, Inc.
500 Nuber Ave.
Mount Vernon,  NY  10550
Correspondent Contact RICHARD E SCORDATO
Regulation Number864.5400
Classification Product Code
KQG  
Date Received03/22/1985
Decision Date 06/24/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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