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FDA 510(k) Application Details - K062013
Device Classification Name
System, Immunomagnetic, Circulating Cancer Cell, Enumeration
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510(K) Number
K062013
Device Name
System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Applicant
VERIDEX, LLC
33 TECHNOLOGY DR.
WARREN, NJ 07059 US
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Contact
DEBRA J RASMUSSEN
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Regulation Number
866.6020
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Classification Product Code
NQI
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Date Received
07/17/2006
Decision Date
12/14/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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