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FDA 510(k) Application Details - K152061
Device Classification Name
System, Test, Thyroid Autoantibody
More FDA Info for this Device
510(K) Number
K152061
Device Name
System, Test, Thyroid Autoantibody
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 BENEDICT AVENUE
TARRYTOWN, NY 10591 US
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Contact
SUSAN BROCCHI
Other 510(k) Applications for this Contact
Regulation Number
866.5870
More FDA Info for this Regulation Number
Classification Product Code
JZO
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More FDA Info for this Product Code
Date Received
07/24/2015
Decision Date
03/03/2016
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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