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FDA 510(k) Application Details - K120771
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K120771
Device Name
Counter, Differential Cell
Applicant
BECKMAN COULTER, INC.
11800 SW 147TH AVE.
MIAMI, FL 33196-2500 US
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Contact
ERIC GRACE
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
03/14/2012
Decision Date
03/22/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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