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FDA 510(k) Application Details - K100999
Device Classification Name
System, Test, Radioallergosorbent (Rast) Immunological
More FDA Info for this Device
510(K) Number
K100999
Device Name
System, Test, Radioallergosorbent (Rast) Immunological
Applicant
PHADIA AB
4169 COMMERCIAL AVENUE
PORTAGE, MI 49002 US
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Contact
MARTIN MANN
Other 510(k) Applications for this Contact
Regulation Number
866.5750
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Classification Product Code
DHB
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More FDA Info for this Product Code
Date Received
04/12/2010
Decision Date
12/15/2010
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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