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FDA 510(k) Application Details - K011855
Device Classification Name
System, Test, C-Reactive Protein
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510(K) Number
K011855
Device Name
System, Test, C-Reactive Protein
Applicant
CARTER-WALLACE, INC.
P.O. BOX 1001
HALF ACRE ROAD
CRANBURY, NJ 08512 US
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Contact
Maureen Garner
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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
06/13/2001
Decision Date
01/08/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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