FDA 510(k) Application Details - K060110

Device Classification Name System, Immunomagnetic, Circulating Cancer Cell, Enumeration

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510(K) Number K060110
Device Name System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Applicant IMMUNICON CORP.
3401 MASONS MILL RD. STE 100
HUNTINGDON VALLEY, PA 19006-3574 US
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Contact PETER SCOTT
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Regulation Number 866.6020

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Classification Product Code NQI
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Date Received 01/17/2006
Decision Date 03/16/2006
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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