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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 K931206
Device Name ELECTRA 1600C AUTOMATIC COAGULATION TIMER
Applicant
MEDICAL LABORATORY AUTOMATION SYSTEMS, INC.
270 MARBLE AVE.
PLEASANTVILLE,  NY  10570
Applicant Contact JOANN HANCHROW
Correspondent
MEDICAL LABORATORY AUTOMATION SYSTEMS, INC.
270 MARBLE AVE.
PLEASANTVILLE,  NY  10570
Correspondent Contact JOANN HANCHROW
Regulation Number864.5400
Classification Product Code
GKP  
Date Received03/10/1993
Decision Date 08/23/1993
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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