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FDA 510(k) Application Details - K040811
Device Classification Name
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
More FDA Info for this Device
510(K) Number
K040811
Device Name
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Applicant
PHARMACIA DEUTSCHLAND GMBH
DIAGNOSTICS DIVISION
MUNZINGER STRASSE 7
FREIBURG D-79111 DE
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Contact
MICHAEL LINSS
Other 510(k) Applications for this Contact
Regulation Number
866.5100
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Classification Product Code
LRM
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More FDA Info for this Product Code
Date Received
03/29/2004
Decision Date
05/13/2004
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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