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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
510(k) Number K896097
Device Name VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
Applicant
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042
Applicant Contact CAROL K GRAVENS
Correspondent
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042
Correspondent Contact CAROL K GRAVENS
Regulation Number866.3480
Classification Product Code
GQG  
Date Received10/20/1989
Decision Date 02/26/1990
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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