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FDA 510(k) Application Details - K983740
Device Classification Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
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510(K) Number
K983740
Device Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Applicant
COLUMBIA BIOSCIENCE, INC.
8775 M CENTRE PARK DR.
#559
COLUMBIA, MD 21045 US
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Contact
NORMAN JENKINS
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Regulation Number
866.5660
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Classification Product Code
MOB
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More FDA Info for this Product Code
Date Received
10/22/1998
Decision Date
11/18/1998
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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