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FDA 510(k) Application Details - K150155
Device Classification Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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510(K) Number
K150155
Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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
866.5100
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Classification Product Code
DHN
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More FDA Info for this Product Code
Date Received
01/23/2015
Decision Date
04/08/2015
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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