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FDA 510(k) Application Details - K133404
Device Classification Name
Ige, Antigen, Antiserum, Control
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510(K) Number
K133404
Device Name
Ige, Antigen, Antiserum, Control
Applicant
PHADIA AB
4169 COMMERCIAL AVE.
PORTAGE, MI 49002 US
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Contact
MARTIN R MANN
Other 510(k) Applications for this Contact
Regulation Number
866.5510
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Classification Product Code
DGC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/06/2013
Decision Date
02/24/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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