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FDA 510(k) Application Details - K041882
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K041882
Device Name
Counter, Differential Cell
Applicant
POINTCARE TECHNOLOGIES INC.
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact
CYNTHIA A SINCLAIR
Other 510(k) Applications for this Contact
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
07/12/2004
Decision Date
11/23/2004
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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