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FDA 510(k) Application Details - K160265
Device Classification Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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510(K) Number
K160265
Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant
Immuno Concepts, NA, Ltd.
9825 Goethe Road; Suite 350
Sacramento, CA 95827 US
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Contact
Eric S. Hoy
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Regulation Number
866.5100
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Classification Product Code
DHN
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More FDA Info for this Product Code
Date Received
02/02/2016
Decision Date
06/17/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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