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FDA 510(k) Application Details - K965053
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K965053
Device Name
Counter, Differential Cell
Applicant
BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
2350 QUME DR.
SAN JOSE, CA 95131-1807 US
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Contact
ANNA LONGWELL, ESQ.
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
12/18/1996
Decision Date
11/21/1997
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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