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FDA 510(k) Application Details - K053497
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K053497
Device Name
Counter, Differential Cell
Applicant
GUAVA TECHNOLOGIES, INC.
25801 INDUSTRIAL BLVD.
HAYWARD, CA 94545 US
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Contact
LAWRENCE F BRUDER
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
12/15/2005
Decision Date
04/14/2006
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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