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FDA 510(k) Application Details - K960427
Device Classification Name
Counter, Differential Cell
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510(K) Number
K960427
Device Name
Counter, Differential Cell
Applicant
SEQUOIA TURNER CORP.
5440 PATRICK HENRY DR.
SANTA CLARA, CA 95054 US
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Contact
JANICE E BROWN
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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
01/29/1996
Decision Date
05/02/1996
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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