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FDA 510(k) Application Details - K033861
Device Classification Name
Dna-Reagents, Legionella
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510(K) Number
K033861
Device Name
Dna-Reagents, Legionella
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
866.3300
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Classification Product Code
LQH
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More FDA Info for this Product Code
Date Received
12/12/2003
Decision Date
03/09/2004
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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