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FDA 510(k) Application Details - K072149
Device Classification Name
Extractable Antinuclear Antibody, Antigen And Control
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510(K) Number
K072149
Device Name
Extractable Antinuclear Antibody, Antigen And Control
Applicant
PHADIA US INC.
4169 COMMERCIAL AVE.
PORTAGE, MI 49002 US
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Contact
MARTIN MANN
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Regulation Number
866.5100
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Classification Product Code
LLL
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More FDA Info for this Product Code
Date Received
08/03/2007
Decision Date
01/15/2008
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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