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FDA 510(k) Application Details - K071652
Device Classification Name
Counter, Cell, Automated (Particle Counter)
More FDA Info for this Device
510(K) Number
K071652
Device Name
Counter, Cell, Automated (Particle Counter)
Applicant
HEMOCUE AB
40 EMPIRE DRIVE
LAKE FOREST, CA 92630 US
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Contact
ALLAN WHITE
Other 510(k) Applications for this Contact
Regulation Number
864.5200
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Classification Product Code
GKL
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More FDA Info for this Product Code
Date Received
06/18/2007
Decision Date
10/25/2007
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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