FDA 510(k) Application Details - K022133

Device Classification Name Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

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510(K) Number K022133
Device Name Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Applicant BECTON DICKINSON & CO.
7 LOVETON CIR.
SPARKS, MD 21152-0999 US
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Contact COLLEEN A KISTLER
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Regulation Number 866.3480

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Classification Product Code GQG
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Date Received 07/01/2002
Decision Date 12/10/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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