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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 K862743
Device Name PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
Applicant
Kallestad Laboratories, Inc.
2000 Interfirst Tower
Austin,  TX  78701
Applicant Contact SUSAN U NEILL
Correspondent
Kallestad Laboratories, Inc.
2000 Interfirst Tower
Austin,  TX  78701
Correspondent Contact SUSAN U NEILL
Regulation Number866.3480
Classification Product Code
GQG  
Date Received07/21/1986
Decision Date 09/29/1986
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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