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FDA 510(k) Application Details - K023857
Device Classification Name
Antigen, Galactomannan, Aspergillus Spp.
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510(K) Number
K023857
Device Name
Antigen, Galactomannan, Aspergillus Spp.
Applicant
BIO-RAD
CLINICAL DIAGNOSTICS GROUP
6565 185TH AVENUE NE
REDMOND, WA 98052 US
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Contact
CHRISTOPHER BENTSEN
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Regulation Number
866.3040
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Classification Product Code
NOM
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More FDA Info for this Product Code
Date Received
11/20/2002
Decision Date
05/16/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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