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FDA 510(k) Application Details - K972145
Device Classification Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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510(K) Number
K972145
Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant
IMMUNO CONCEPTS, INC.
9779 BUSINESS PARK DR.
SUITE D
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
06/06/1997
Decision Date
02/24/1998
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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