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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 K780810
Device Name MLA ELECTRA 750 COAGULATION TIMER
Applicant
Medical Laboratory Automation Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medical Laboratory Automation Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.5425
Classification Product Code
JPA  
Date Received05/18/1978
Decision Date 06/14/1978
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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