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FDA 510(k) Application Details - K192095
Device Classification Name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
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510(K) Number
K192095
Device Name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Applicant
Sebia
1705 Corporate Drive Suite 400
Norcross, GA 30093 US
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Contact
Karen Anderson
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Regulation Number
866.5510
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Classification Product Code
CFF
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More FDA Info for this Product Code
Date Received
08/05/2019
Decision Date
11/01/2019
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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