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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, Automated
510(k) Number K944227
Device Name ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER
Applicant
MEDICAL LABORATORY AUTOMATION SYSTEMS, INC.
270 MARBLE AVE.
PLEASANTVILLE,  NY  10570
Applicant Contact JOANN H LOPEZ
Correspondent
MEDICAL LABORATORY AUTOMATION SYSTEMS, INC.
270 MARBLE AVE.
PLEASANTVILLE,  NY  10570
Correspondent Contact JOANN H LOPEZ
Regulation Number864.5400
Classification Product Code
GKP  
Date Received09/01/1994
Decision Date 02/03/1995
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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