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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 K870176
Device Name GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT
Applicant
Genetic Systems Corp.
3005 First Ave.
Seattle,  WA  98121
Applicant Contact BOGDAN DZIURZYNSKI
Correspondent
Genetic Systems Corp.
3005 First Ave.
Seattle,  WA  98121
Correspondent Contact BOGDAN DZIURZYNSKI
Regulation Number866.3480
Classification Product Code
LKT  
Date Received01/15/1987
Decision Date 07/16/1987
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
Recalls CDRH Recalls
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