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FDA 510(k) Application Details - K091052
Device Classification Name
System, Test, C-Reactive Protein
More FDA Info for this Device
510(K) Number
K091052
Device Name
System, Test, C-Reactive Protein
Applicant
ABAXIS, INC.
3240 WHIPPLE RD.
UNION CITY, CA 94587 US
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Contact
Dennis M Bleile
Other 510(k) Applications for this Contact
Regulation Number
866.5270
More FDA Info for this Regulation Number
Classification Product Code
DCN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/13/2009
Decision Date
01/15/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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