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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 K864534
Device Name ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER
Applicant
Medical Laboratory Automation Systems, Inc.
270 Marble Ave.
Pleasantville,  NY  10570
Applicant Contact JOHN V BELLIOTTI
Correspondent
Medical Laboratory Automation Systems, Inc.
270 Marble Ave.
Pleasantville,  NY  10570
Correspondent Contact JOHN V BELLIOTTI
Regulation Number864.5425
Classification Product Code
JPA  
Date Received11/17/1986
Decision Date 02/06/1987
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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