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FDA 510(k) Application Details - K143329
Device Classification Name
More FDA Info for this Device
510(K) Number
K143329
Device Name
AmpliVue Trichomonas Assay
Applicant
QUIDEL CORPORATION
2005 EAST STATE STREET
SUITE 100
ATHENS, OH 45701 US
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Contact
RONALD H LOLLAR
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Regulation Number
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Classification Product Code
OUY
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Date Received
11/20/2014
Decision Date
03/17/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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