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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Cf, Cytomegalovirus
510(k) Number K843189
Device Name CYTOMEGALOVIRUS IGG EIA TEST KIT
Applicant
Labsystems, Inc.
IL  60648
Correspondent
Labsystems, Inc.
IL  60648
Regulation Number866.3175
Classification Product Code
GQI  
Date Received08/13/1984
Decision Date 01/08/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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