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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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