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FDA 510(k) Application Details - K062840
Device Classification Name
Plasma, Coagulation Control
More FDA Info for this Device
510(K) Number
K062840
Device Name
Plasma, Coagulation Control
Applicant
BIOSITE INCORPORATED
9975 SUMMERS RIDGE RD
SAN DIEGO, CA 92121 US
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Contact
FIL V BUENVIAJE
Other 510(k) Applications for this Contact
Regulation Number
864.5425
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Classification Product Code
GGN
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More FDA Info for this Product Code
Date Received
09/22/2006
Decision Date
03/01/2007
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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