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FDA 510(k) Application Details - K092919
Device Classification Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
More FDA Info for this Device
510(K) Number
K092919
Device Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
1584 ENTERPRISE BLVD
WEST SACRAMENTO, CA 95691 US
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Contact
SHANNON POPSON
Other 510(k) Applications for this Contact
Regulation Number
866.1645
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Classification Product Code
LON
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More FDA Info for this Product Code
Date Received
09/23/2009
Decision Date
10/23/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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