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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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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