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FDA 510(k) Application Details - K031857
Device Classification Name
Alpha-1-Antitrypsin, Antigen, Antiserum, Control
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510(K) Number
K031857
Device Name
Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Applicant
BAYER DIAGNOSTICS CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
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Contact
ANDRES HOLLE
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Regulation Number
866.5130
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Classification Product Code
DEM
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More FDA Info for this Product Code
Date Received
06/16/2003
Decision Date
09/04/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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