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FDA 510(k) Application Details - K113143
Device Classification Name
Extractable Antinuclear Antibody, Antigen And Control
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510(K) Number
K113143
Device Name
Extractable Antinuclear Antibody, Antigen And Control
Applicant
IMMCO DIAGNOSTICS, INC.
60 PINEVIEW DR.
BUFFALO, NY 14228-2120 US
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Contact
KEVIN J LAWSON
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Regulation Number
866.5100
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Classification Product Code
LLL
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Date Received
10/25/2011
Decision Date
12/02/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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