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FDA 510(k) Application Details - K082091
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K082091
Device Name
Counter, Differential Cell
Applicant
REAMETRIX INC.
1585 INDUSTRIAL RD.
SAN CARLOS, CA 94070 US
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Contact
STEVE KUNITAKE
Other 510(k) Applications for this Contact
Regulation Number
864.5220
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Classification Product Code
GKZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/24/2008
Decision Date
04/15/2009
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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