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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 K862705
Device Name CYTOMEGALOVIRUS IGG EIA TEST KIT
Applicant
Labsystems, Inc.
P.O. Box 48723
Chicago,  IL  60648
Applicant Contact NANCY J SKOWRONSKI
Correspondent
Labsystems, Inc.
P.O. Box 48723
Chicago,  IL  60648
Correspondent Contact NANCY J SKOWRONSKI
Regulation Number866.3175
Classification Product Code
GQI  
Date Received07/16/1986
Decision Date 10/01/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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