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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Syncytial Virus, Antigen, Antibody, Ifa
510(k) Number K861379
Device Name MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT
Applicant
Serono Diagnostics, Inc.
100 Longwater Circle
Norwell,  MA  02061
Applicant Contact PHILIP M FANTASIA
Correspondent
Serono Diagnostics, Inc.
100 Longwater Circle
Norwell,  MA  02061
Correspondent Contact PHILIP M FANTASIA
Regulation Number866.3480
Classification Product Code
LKT  
Date Received04/14/1986
Decision Date 07/16/1986
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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