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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 K853695
Device Name RESPIRATORY SYNCYTIAL VIRUS ID REAGENT
Applicant
Viromed Laboratories, Inc.
5100 Gamble Dr.
Suite 55
Minneapolis,  MN  55416
Applicant Contact BONITA BASKIN
Correspondent
Viromed Laboratories, Inc.
5100 Gamble Dr.
Suite 55
Minneapolis,  MN  55416
Correspondent Contact BONITA BASKIN
Regulation Number866.3480
Classification Product Code
GQG  
Date Received09/04/1985
Decision Date 12/04/1985
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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