FDA 510(k) Application Details - K112523

Device Classification Name System, Test, Radioallergosorbent (Rast) Immunological

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510(K) Number K112523
Device Name System, Test, Radioallergosorbent (Rast) Immunological
Applicant Siemens Healthcare Diagnostics Inc.
511 BENEDICT AVE.
TARRYTOWN, NY 10591 US
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Contact Garo Mimaryan
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Regulation Number 866.5750

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Classification Product Code DHB
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Date Received 08/31/2011
Decision Date 01/06/2012
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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