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FDA 510(k) Application Details - K112276
Device Classification Name
Manual Antimicrobial Susceptibility Test Systems
More FDA Info for this Device
510(K) Number
K112276
Device Name
Manual Antimicrobial Susceptibility Test Systems
Applicant
TREK DIAGNOSTIC SYSTEMS
982 KEYNOTE CIRCLE
CLEVELAND, OH 44131 US
Other 510(k) Applications for this Company
Contact
CYNTHIA C KNAPP
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
08/09/2011
Decision Date
11/16/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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