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FDA 510(k) Application Details - K051282
Device Classification Name
Microscope, Automated, Image Analysis, Operator Intervention
More FDA Info for this Device
510(K) Number
K051282
Device Name
Microscope, Automated, Image Analysis, Operator Intervention
Applicant
TRIPATH IMAGING, INC.
4025 STIRRUP CREEK DRIVE
STE. 400
DURHAM, NC 27703 US
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Contact
BRYAN J TUCKER
Other 510(k) Applications for this Contact
Regulation Number
864.1860
More FDA Info for this Regulation Number
Classification Product Code
NOT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2005
Decision Date
08/16/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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