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FDA 510(k) Application Details - K062516
Device Classification Name
Immunochemical, Thyroglobulin Autoantibody
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510(K) Number
K062516
Device Name
Immunochemical, Thyroglobulin Autoantibody
Applicant
BECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA, MN 55318-1084 US
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Contact
TYLER FOUTCH
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Regulation Number
866.5870
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Classification Product Code
JNL
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Date Received
08/28/2006
Decision Date
10/05/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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