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FDA 510(k) Application Details - K062981
Device Classification Name
System, Test, C-Reactive Protein
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510(K) Number
K062981
Device Name
System, Test, C-Reactive Protein
Applicant
BODITECH DIAGNOSTICS, INC.
150 CHERRY LANE RD.
EAST STROUDSBURG, PA 18301 US
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Contact
Gary Lehnus
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Regulation Number
866.5270
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Classification Product Code
DCN
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More FDA Info for this Product Code
Date Received
09/29/2006
Decision Date
07/13/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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