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FDA 510(k) Application Details - K140396
Device Classification Name
Lambda, Antigen, Antiserum, Control
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510(K) Number
K140396
Device Name
Lambda, Antigen, Antiserum, Control
Applicant
THE BINDING SITE GROUP, LTD.
5889 OBDERLIN DR., STE 101
SAN DIEGO, CA 92121 US
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Contact
DOUG KURTH
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Regulation Number
866.5550
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Classification Product Code
DEH
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More FDA Info for this Product Code
Date Received
02/18/2014
Decision Date
04/16/2014
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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