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FDA 510(k) Application Details - K080523
Device Classification Name
Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
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510(K) Number
K080523
Device Name
Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
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
NST
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Date Received
02/26/2008
Decision Date
06/17/2008
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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