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FDA 510(k) Application Details - K053012
Device Classification Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
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510(K) Number
K053012
Device Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Applicant
BIOMEDICAL DIAGNOSTICS (BMD) SA
ACTIPOLE 25
4-6 BLD DE BEAUBOURG
MARNE LA VALLEE CEDEX 2 77435 FR
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Contact
CHRISTELLE COURIVAUD
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Regulation Number
866.5660
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Classification Product Code
MOB
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Date Received
10/26/2005
Decision Date
03/02/2006
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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