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FDA 510(k) Application Details - K052793
Device Classification Name
Antibodies, Gliadin
More FDA Info for this Device
510(K) Number
K052793
Device Name
Antibodies, Gliadin
Applicant
PHARMACIA DIAGNOSTICS AB
4169 COMMERCIAL AVENUE
PORTAGE, MI 49002 US
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Contact
MARTIN R MANN
Other 510(k) Applications for this Contact
Regulation Number
866.5750
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Classification Product Code
MST
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More FDA Info for this Product Code
Date Received
10/03/2005
Decision Date
02/07/2006
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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