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FDA 510(k) Application Details - K091949
Device Classification Name
Panels, Test, Susceptibility, Antimicrobial
More FDA Info for this Device
510(K) Number
K091949
Device Name
Panels, Test, Susceptibility, Antimicrobial
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
1584 ENTERPRISE BLVD
WEST SACRAMENTO, CA 95691 US
Other 510(k) Applications for this Company
Contact
SHANNON POPSON
Other 510(k) Applications for this Contact
Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
LTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/01/2009
Decision Date
01/26/2010
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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