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FDA 510(k) Application Details - K002559
Device Classification Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
More FDA Info for this Device
510(K) Number
K002559
Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Applicant
THERATEST LABORATORIES, INC.
2201 WEST CAMPBELL PARK DR.
CHICAGO, IL 60612-3501 US
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Contact
MARIUS TEODORESCU
Other 510(k) Applications for this Contact
Regulation Number
866.5100
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Classification Product Code
LJM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/17/2000
Decision Date
09/12/2000
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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