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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 K912371
Device Name BIOMERIEUX RSV DIRECT IF KIT
Applicant
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042
Applicant Contact CHERYL WINTERS-HEARD
Correspondent
Vitek Systems, Inc.
595 Anglum Dr.
Hazelwood,  MI  63042
Correspondent Contact CHERYL WINTERS-HEARD
Regulation Number866.3480
Classification Product Code
LKT  
Date Received05/29/1991
Decision Date 09/23/1991
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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