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FDA 510(k) Application Details - K954688
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K954688
Device Name
Counter, Differential Cell
Applicant
COULTER CORP.
11800 S.W. 147TH AVE.
MIAMI, FL 33196-2500 US
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Contact
MARION S GAIDE
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
10/11/1995
Decision Date
02/29/1996
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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