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FDA 510(k) Application Details - K024221
Device Classification Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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510(K) Number
K024221
Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant
BIO-RAD
9500 JERONIMO RD.
IRVINE, CA 92618-2017 US
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Contact
Yvette Lloyd
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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
12/23/2002
Decision Date
01/15/2003
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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