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FDA 510(k) Application Details - K040953
Device Classification Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
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510(K) Number
K040953
Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Applicant
AESKU, INC
8880 NORTHWEST 18TH TERRACE
MIAMI, FL 33172 US
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Contact
STANLEY AMMONS
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Regulation Number
866.5100
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Classification Product Code
LJM
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Date Received
04/12/2004
Decision Date
06/23/2004
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
N
Expedited Review
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