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FDA 510(k) Application Details - K111956
Device Classification Name
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510(K) Number
K111956
Device Name
KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
Applicant
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
170 S SENECA SPRINGS WAY
SUITE 105
STAR, ID 83669 US
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Contact
HEATHER VIELE
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Regulation Number
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Classification Product Code
PAF
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Date Received
07/11/2011
Decision Date
05/30/2012
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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