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FDA 510(k) Application Details - K032518
Device Classification Name
Manual Antimicrobial Susceptibility Test Systems
More FDA Info for this Device
510(K) Number
K032518
Device Name
Manual Antimicrobial Susceptibility Test Systems
Applicant
BD DIAGNOSTIC SYSTEMS
12750 W. 42ND AVENUE
WHEAT RIDGE, CO 80033-2440 US
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Contact
LINDA K DILLON
Other 510(k) Applications for this Contact
Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
JWY
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More FDA Info for this Product Code
Date Received
08/14/2003
Decision Date
09/15/2003
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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