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FDA 510(k) Application Details - K082759
Device Classification Name
Antinuclear Antibody, Antigen, Control
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510(K) Number
K082759
Device Name
Antinuclear Antibody, Antigen, Control
Applicant
PHADIA US INC.
4169 COMMERCIAL AVE.
PORTAGE, MI 49002 US
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Contact
MARTIN R MANN
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Regulation Number
866.5100
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Classification Product Code
LKJ
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More FDA Info for this Product Code
Date Received
09/22/2008
Decision Date
04/10/2009
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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