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FDA 510(k) Application Details - K140493
Device Classification Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
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510(K) Number
K140493
Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Applicant
PHADIA GMBH
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
LJM
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More FDA Info for this Product Code
Date Received
02/27/2014
Decision Date
10/30/2014
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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