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FDA 510(k) Application Details - K023369
Device Classification Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
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510(K) Number
K023369
Device Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Applicant
BECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA, MN 55318-1084 US
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Contact
DENISE THOMPSON
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Regulation Number
862.1700
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Classification Product Code
KLI
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More FDA Info for this Product Code
Date Received
10/08/2002
Decision Date
12/09/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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