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FDA 510(k) Application Details - K181556
Device Classification Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
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510(K) Number
K181556
Device Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Applicant
Phadia AB
Rapsgatan 7P
Uppsala SE 754 50 SE
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Contact
Carina Magnusson
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Regulation Number
866.5090
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Classification Product Code
DBM
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Date Received
06/13/2018
Decision Date
07/13/2018
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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