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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 K882687
Device Name ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST
Applicant
Gull Laboratories, Inc.
1011 E. 4800 S.
Salt Lake City,  UT  84117
Applicant Contact RACHFORD, PHD
Correspondent
Gull Laboratories, Inc.
1011 E. 4800 S.
Salt Lake City,  UT  84117
Correspondent Contact RACHFORD, PHD
Regulation Number866.3480
Classification Product Code
LKT  
Date Received06/30/1988
Decision Date 08/30/1988
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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