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FDA 510(k) Application Details - K100722
Device Classification Name
Susceptibility Test Discs, Antimicrobial
More FDA Info for this Device
510(K) Number
K100722
Device Name
Susceptibility Test Discs, Antimicrobial
Applicant
Becton, Dickinson and Company
7 LOVETON CIRCLE, MC 614
SPARKS, MD 21152 US
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Contact
JANINE SPAFFORD
Other 510(k) Applications for this Contact
Regulation Number
866.1620
More FDA Info for this Regulation Number
Classification Product Code
JTN
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More FDA Info for this Product Code
Date Received
03/15/2010
Decision Date
03/29/2010
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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