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FDA 510(k) Application Details - K022668
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K022668
Device Name
Counter, Differential Cell
Applicant
BAYER DIAGNOSTICS CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
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Contact
KENNETH T EDDS
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
08/12/2002
Decision Date
10/15/2002
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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