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FDA 510(k) Application Details - K051061
Device Classification Name
Autoantibodies, Glutamic Acid Decarboxylase (Gad)
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510(K) Number
K051061
Device Name
Autoantibodies, Glutamic Acid Decarboxylase (Gad)
Applicant
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
12554 WEST BRIDGER ST.
SUITE 108
BOISE, ID 83713 US
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MEATHER VIELE
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Regulation Number
866.5660
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Classification Product Code
NWG
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Date Received
04/26/2005
Decision Date
11/04/2005
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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