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FDA 510(k) Application Details - K030263
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K030263
Device Name
Counter, Differential Cell
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
864.5220
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Classification Product Code
GKZ
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More FDA Info for this Product Code
Date Received
01/27/2003
Decision Date
11/24/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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