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FDA 510(k) Application Details - K042680
Device Classification Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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510(K) Number
K042680
Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant
CORGENIX, INC.
455 STATE STREET
DES PLAINES, IL 60016 US
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Contact
YUSUKE KOBE
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Regulation Number
866.5100
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Classification Product Code
DHN
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Date Received
09/29/2004
Decision Date
11/19/2004
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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