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FDA 510(k) Application Details - K073590
Device Classification Name
Tyrosine Phosphatase (Ia-2) Autoantibody Assay
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510(K) Number
K073590
Device Name
Tyrosine Phosphatase (Ia-2) Autoantibody Assay
Applicant
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
12554 WEST BRIDGER ST.
SUITE 108
BOISE, ID 83713 US
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HEATHER VIELE
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Regulation Number
866.5660
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Classification Product Code
OIF
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Date Received
12/20/2007
Decision Date
04/10/2008
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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