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FDA 510(k) Application Details - K041445
Device Classification Name
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
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510(K) Number
K041445
Device Name
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DR.
CINCINNATI, OH 45244 US
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Contact
SUSAN ROLIH
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Regulation Number
866.3480
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Classification Product Code
GQG
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More FDA Info for this Product Code
Date Received
06/01/2004
Decision Date
08/13/2004
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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