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FDA 510(k) Application Details - K050057
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K050057
Device Name
Counter, Differential Cell
Applicant
BECKMAN COULTER, INC.
11800 SW 147TH AVE.
M/S 31-B06
MIAMI, FL 33196-2500 US
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Contact
STAN SUGRUE
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
01/11/2005
Decision Date
02/10/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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