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FDA 510(k) Application Details - K050191
Device Classification Name
More FDA Info for this Device
510(K) Number
K050191
Device Name
MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
Applicant
BECTON DICKINSON & CO.
2350 Qume Drive
San Jose, CA 95131 US
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Contact
CARTER NAVARRO
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Regulation Number
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Classification Product Code
PER
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More FDA Info for this Product Code
Date Received
01/27/2005
Decision Date
02/22/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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