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FDA 510(k) Application Details - K011031
Device Classification Name
System, Test, Tumor Marker, Monitoring, Bladder
More FDA Info for this Device
510(K) Number
K011031
Device Name
System, Test, Tumor Marker, Monitoring, Bladder
Applicant
VYSIS
3100 WOODCREEK DR.
DOWNERS GROVE, IL 60515 US
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Contact
RUSSEL K ENNS
Other 510(k) Applications for this Contact
Regulation Number
866.6010
More FDA Info for this Regulation Number
Classification Product Code
MMW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/05/2001
Decision Date
08/03/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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