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FDA 510(k) Application Details - K062306
Device Classification Name
Control, Plasma, Abnormal
More FDA Info for this Device
510(K) Number
K062306
Device Name
Control, Plasma, Abnormal
Applicant
R2 DIAGNOSTICS, INC.
1801 COMMERCE DR.
SOUTH BEND, IN 46628 US
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Contact
MARC GOLDFORD
Other 510(k) Applications for this Contact
Regulation Number
864.5425
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Classification Product Code
GGC
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More FDA Info for this Product Code
Date Received
08/08/2006
Decision Date
03/16/2007
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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