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FDA 510(k) Application Details - K081930
Device Classification Name
Counter, Differential Cell
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510(K) Number
K081930
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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LOURDES COBA
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Regulation Number
864.5220
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Classification Product Code
GKZ
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Date Received
07/07/2008
Decision Date
12/19/2008
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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