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FDA 510(k) Application Details - K143754
Device Classification Name
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
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510(K) Number
K143754
Device Name
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Applicant
INOVA DIAGNOSTICS, INC.
9900 OLD GROVE ROAD
SAN DIEGO, CA 92131 US
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Contact
Gabriella Lakos
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Regulation Number
866.5775
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Classification Product Code
NHX
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More FDA Info for this Product Code
Date Received
12/31/2014
Decision Date
09/21/2015
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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