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FDA 510(k) Application Details - K122197
Device Classification Name
System, Test, Radioallergosorbent (Rast) Immunological
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510(K) Number
K122197
Device Name
System, Test, Radioallergosorbent (Rast) Immunological
Applicant
PHADIA US INC.
4169 COMMERCIAL AVE.
PORTAGE, MI 49002 US
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Contact
MARTIN MANN
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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
07/24/2012
Decision Date
08/28/2013
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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