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FDA 510(k) Application Details - K072869
Device Classification Name
Counter, Differential Cell
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510(K) Number
K072869
Device Name
Counter, Differential Cell
Applicant
POINTCARE TECHNOLOGIES INC.
181 CEDAR HILL ST.
MARLBOROUGH, MA 01752 US
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Contact
MAURICE N DOIRE
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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
10/09/2007
Decision Date
01/14/2008
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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