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FDA 510(k) Application Details - K181475
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K181475
Device Name
Counter, Differential Cell
Applicant
Beckman Coulter
11800 SW 147th Ave
Miami, FL 33196-2500 US
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Contact
Samy Puccio
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
06/04/2018
Decision Date
03/01/2019
Decision
SESU - SE - WITH LIMITATIONS
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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