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FDA 510(k) Application Details - K083615
Device Classification Name
Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
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510(K) Number
K083615
Device Name
Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
Applicant
EUROIMMUN US INC
95 WASHINGTON ST
MORRISTOWN, NJ 07960 US
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Contact
KATHRYN KOHL
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Regulation Number
866.5660
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Classification Product Code
OEG
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Date Received
12/08/2008
Decision Date
03/16/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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