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FDA 510(k) Application Details - K051144
Device Classification Name
Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
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510(K) Number
K051144
Device Name
Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
Applicant
IBL-HAMBURG GMBH
150 CHERRY LANE RD.
EAST STROUDSBURG, PA 18301 US
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Contact
Gary Lehnus
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Regulation Number
866.5660
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Classification Product Code
NST
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Date Received
05/04/2005
Decision Date
11/18/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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